FDA warning letters, recalls and 483s for compounding pharmacies (2024–2026)
AffinityRx tracks FDA warning letters, recalls and Form 483s for compounding pharmacies so clinics don't have to: AffinityRx vets every pharmacy (only 9% of those reviewed pass), notifies clinics if a pharmacy on the platform receives a warning letter or recall, updates that pharmacy's profile, and lets clinics switch the pharmacy off in their portal. The index below lists 306 FDA actions involving human-drug compounding pharmacies and outsourcing facilities from Aug 31, 2016 through Oct 1, 2026: 30 warning letters, 85 recalls, 116 Form 483s, and 75 other actions (including older actions involving pharmacies on AffinityRx). 46 involve pharmacies that are on AffinityRx and are highlighted below with a link to the pharmacy profile. Each record links to the FDA source; the index was last checked Oct 1, 2026.
306
FDA actions listed
2016 to 2026
30
Warning Letters
in the index
85
Recalls
in the index
116
Form 483s
in the index
46
Involve AffinityRx pharmacies
highlighted
Last checked · By Tim Yoon, CEO, AffinityRx · Last updated
FDA actions involving pharmacies on AffinityRx
46 of the 306 listed FDA actions involve a pharmacy that is on AffinityRx. They are shown here, and again in the full table, so clinics can review them on the pharmacy profile.
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Semaglutide, Tirzepatide, Cyanocobalamin | Following a 2025-11-03 to 2025-11-14 inspection of Empower Pharmacy's 503A facility (Houston, TX), FDA issued a Warning Letter citing compounding of products that are essentially copies of FDA-approved semaglutide and tirzepatide products regularly and in inordinate amounts (e.g., tirzepatide/niacinamide, semaglutide/cyanocobalamin), plus inadequate smoke studies, media fills and CGMP deficiencies. The letter reviews Empower responses dated 2025-12-08, 2026-03-18 and 2026-04-30.Status: Issued | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Other | Not specified in source | FDA issued a close-out letter on 2026-05-13 for Warning Letter 639220 (issued 2022-08-29 to Vita Pharmacy LLC dba Talon Pharmacy of Boerne; FDA's close-out page is titled Strive Pharmacy Texas LLC). FDA lists it under Vita Pharmacy dba Talon Compounding Pharmacy, San Antonio, TX.Status: Closed out | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, Sermorelin, Tesamorelin, NAD+, Gonadorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2026-03-27, listing inspectional observations from an inspection dated 3/9/2026-3/27/2026. The form lists 5 observation(s), including: microbial contamination in controlled areas; personnel practices; airflow (smoke) studies; ISO 5 area practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Semaglutide, Glutathione, Testosterone, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2025-11-14. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; cleaning/disinfection; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Tirzepatide, Testosterone | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2025-11-14. The form lists 6 observation(s), including: microbial contamination in controlled areas; cleaning/disinfection; personnel practices; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2025-01-27 to 2025-02-07 inspection of Revive Rx Pharmacy (503A, Houston, TX), FDA issued a Warning Letter citing insanitary sterile-processing conditions: exposure of sterile product to worse-than-specified air quality, microbial contamination without adequate evaluation, media fills not under worst-case conditions, inadequate smoke studies and sterilization/environmental-monitoring gaps.Status: Issued | FDA record | |
| Empower Clinic Services, LLC dba Empower PharmacyOn AffinityRx | Recall | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Em | Empower Clinic Services, LLC dba Empower Pharmacy initiated a recall (recall initiation 2025-05-02; reported in the FDA Enforcement Report 2025-05-21) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Glutathione, Testosterone, Cyanocobalamin, Pyridoxine, Estradiol | Following a 2024-08-01 to 2024-08-28 inspection of Empower Pharmacy's 503B outsourcing facility (Houston, TX), FDA issued a Warning Letter citing missing label/container information (e.g., pyridoxine injection), microbial contamination in the ISO 5 area without adequate evaluation, inadequate smoke studies and CGMP violations. It acknowledges Empower's 2024-09-05 recall of pyridoxine HCl 100 mg/mL (lot 609763).Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2024-09-24 to 2024-10-04 inspection of Empower Pharmacy's 503A facility (Houston, TX), FDA issued a Warning Letter citing insanitary sterile-processing conditions: inadequate routine environmental monitoring and ISO 5 certification sampling, media fills not under worst-case conditions, and unsterilized equipment in the ISO 5 area.Status: Issued | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, NAD+, Testosterone, Gonadorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2025-02-07. The form lists 7 observation(s), including: ISO 5 area practices; microbial contamination in controlled areas; environmental monitoring; media fills. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX on 2025-01-22. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, Gonadorelin | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2024-10-04. The form lists 8 observation(s), including: cleaning/disinfection; ISO 5 area practices; media fills; environmental monitoring. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower PharmacyOn AffinityRx | Recall | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX | Empower Pharmacy initiated a recall (recall initiation 2024-09-05; reported in the FDA Enforcement Report 2024-10-02) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Glutathione, Testosterone, Ketamine, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2024-08-28, listing inspectional observations from an inspection dated 8/1/2024-8/28/2024. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; laboratory testing/release; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| EMPOWER CLINIC SERVICES LLCOn AffinityRx | Recall | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use onl | EMPOWER CLINIC SERVICES LLC initiated a recall (recall initiation 2024-08-02; reported in the FDA Enforcement Report 2024-08-14) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Rev | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2024-04-20; reported in the FDA Enforcement Report 2024-06-05) covering 1 product listing(s). FDA's stated reason: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | NAD+ | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2023-12-01. The form lists 8 observation(s), including: ISO 5 area practices; cleaning/disinfection; environmental monitoring; component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Strive Pharmacy Texas, LLC, dba Strive Pharmacy (formerly Talon Pharmacy of Boerne) Boerne, TXOn AffinityRx | Form 483 | Semaglutide | FDA issued a Form FDA 483 to Strive Pharmacy Texas, LLC, dba Strive Pharmacy (formerly Talon Pharmacy of Boerne) Boerne, TX (503A facility) on 2023-09-08. The form lists 4 observation(s), including: facility design; personnel practices; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Other | Not specified in source | FDA issued an Untitled Letter to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX dated 2023-06-30 following an inspection from April 12, 2022 to May 4, 2022 (Form FDA 483 issued May 4, 2022). The letter states investigators noted deficiencies in drug production practices.Status: Listed | FDA record | |
| Empower Clinic Services LLC dba Empower PharmacyOn AffinityRx | Recall | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded b | Empower Clinic Services LLC dba Empower Pharmacy initiated a recall (recall initiation 2023-05-12; reported in the FDA Enforcement Report 2023-06-14) covering 1 product listing(s). FDA's stated reason: Mislabeling: preservative free product labeled as preserved. Classification: Class II; status: Completed.Class II · Status: Completed | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2023-05-11; reported in the FDA Enforcement Report 2023-05-31) covering 1 product listing(s). FDA's stated reason: Sub-potent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX on 2023-05-04. No further detail is posted on the page.Status: Listed | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2021-10-18 to 2021-11-02 inspection of Vita Pharmacy LLC dba Talon Pharmacy of Boerne (503A, Boerne, TX; later Strive Pharmacy Texas), FDA issued a Warning Letter citing sterile-processing deficiencies: airflow/design concerns, hazardous drugs handled in the same cleanroom as non-hazardous products, dirty equipment, no smoke studies and media fills not under worst-case conditions.Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Sermorelin, Ketamine, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2022-08-05, listing inspectional observations from an inspection dated 7/18/2022-8/5/2022. The form lists 17 observation(s), including: quality control unit responsibilities; procedures to prevent microbial contamination of sterile products; cleaning/disinfection; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists a letter referring Promise Pharmacy, LLC, Palm Harbor, FL to its state board of pharmacy, dated 2022-07-27. See the source document for content.Status: Listed | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Promise Pharmacy, LLC, Palm Harbor, FL on 2022-07-27. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA listed a Warning Letter close-out letter for this firm on its compounding actions page.Status: Closed out | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX on 2022-05-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2022-05-04. The form lists 8 observation(s), including: equipment design/maintenance; cleaning/disinfection; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2022-02-11; reported in the FDA Enforcement Report 2022-02-23) covering 1 product listing(s). FDA's stated reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus. Classification: Class I; status: Terminated.Class I · Status: Terminated | FDA record | |
| Vita Pharmacy, LLC dba Talon Compounding PharmacyOn AffinityRx | Recall | Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharm; (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE ; ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive St (+127 more product listings) | Vita Pharmacy, LLC dba Talon Compounding Pharmacy initiated a recall (recall initiation 2021-10-12; reported in the FDA Enforcement Report 2021-11-17) covering 130 product listing(s). FDA's stated reason: Lack of assurance of sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX (503A facility) on 2021-11-02. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Testosterone, Pyridoxine | Following a 2020-02-12 to 2020-03-06 inspection of Empower Pharmacy's 503B outsourcing facility (Houston, TX), FDA issued a Warning Letter citing unapproved-new-drug/misbranding violations for products that did not meet 503B conditions, including pyridoxine 100 mg/mL injection compounded from a non-qualifying bulk substance. It also cites failure to submit complete product reports to FDA (Dec 2019, June 2020).Status: Issued | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX (503A facility) on 2021-10-06. The form lists 3 observation(s), including: cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Form 483 | Bpc-157, Ipamorelin | FDA issued a Form FDA 483 to Promise Pharmacy, LLC, Palm Harbor, FL (503A facility) on 2021-09-23. The form lists 1 observation(s), including: component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLCOn AffinityRx | Recall | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial ste | Promise Pharmacy, LLC initiated a recall (recall initiation 2021-06-30; reported in the FDA Enforcement Report 2021-09-22) covering 1 product listing(s). FDA's stated reason: Lack of processing controls. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Ipamorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2021-08-06. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX on 2020-07-08. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Glutathione, Testosterone, Pyridoxine | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2020-03-06. The form lists 6 observation(s), including: quality control unit responsibilities; labeling required of outsourcing facilities; adverse event reporting. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Form 483 | Estradiol | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX (503A facility) on 2020-02-11. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Warning Letter | Bremelanotide | FDA inspected Promise Pharmacy (503A, Palm Harbor, FL) in 2018 and issued a Form 483 on 2018-10-25 (amended 2018-11-12). The letter cites insanitary sterile-compounding conditions (particulates in a prednisolone/gatifloxacin ophthalmic lot, an inadequate non-hazardous cleanroom, poor aseptic practice) and a released bremelanotide 20 mg injectable that assayed at 114.3% of label strength. It acknowledges recalls on 2018-10-22 and 2018-12-13 and a voluntary pause of sterile operations.Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Sermorelin, Pyridoxine | FDA issued an Untitled Letter to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX dated 2019-07-22 following an inspection from January 10, 2018 to January 24, 2018 (Form FDA 483 issued January 24, 2018). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX on 2019-04-02. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Promise Pharmacy, LLCOn AffinityRx | Recall | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US ; Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription,; Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, (+48 more product listings) | Promise Pharmacy, LLC initiated a recall (recall initiation 2018-12-17; reported in the FDA Enforcement Report 2019-02-20) covering 51 product listing(s). FDA's stated reason: Lack of sterility assurance. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Promise Pharmacy LLCOn AffinityRx | Recall | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Pa | Promise Pharmacy LLC initiated a recall (recall initiation 2018-10-18; reported in the FDA Enforcement Report 2018-10-31) covering 1 product listing(s). FDA's stated reason: Presence of precipitate. Classification: Class III; status: Terminated.Class III · Status: Terminated | FDA record | |
| Talon Compounding PharmacyOn AffinityRx | Recall | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 i; Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by | Talon Compounding Pharmacy initiated a recall (recall initiation 2016-07-19; reported in the FDA Enforcement Report 2016-08-31) covering 2 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record |
An FDA action is a record of an agency finding or event at a point in time. It is not a conclusion about a pharmacy's current status. Compare the date and status with the pharmacy's profile, and verify with FDA.
All FDA actions involving compounding pharmacies, by year
The table lists 306 FDA actions from Aug 31, 2016 through Oct 1, 2026, newest first. Jump to a year: 2026 2025 2024 2023 2022 2021 2020 2019 2018 2016.
2026 60
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Semaglutide, Tirzepatide, Cyanocobalamin | Following a 2025-11-03 to 2025-11-14 inspection of Empower Pharmacy's 503A facility (Houston, TX), FDA issued a Warning Letter citing compounding of products that are essentially copies of FDA-approved semaglutide and tirzepatide products regularly and in inordinate amounts (e.g., tirzepatide/niacinamide, semaglutide/cyanocobalamin), plus inadequate smoke studies, media fills and CGMP deficiencies. The letter reviews Empower responses dated 2025-12-08, 2026-03-18 and 2026-04-30.Status: Issued | FDA record | |
| ImprimisRx NJ LLC | Recall | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use On | ImprimisRx NJ LLC initiated a recall (recall initiation 2026-08-24; reported in the FDA Enforcement Report 2026-09-16) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| OurPharma LLC | Recall | fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 | OurPharma LLC initiated a recall (recall initiation 2026-09-03; reported in the FDA Enforcement Report 2026-09-16) covering 1 product listing(s). FDA's stated reason: Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| OPTIMAL BALANCE PHARMACY | Recall | Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Al | OPTIMAL BALANCE PHARMACY initiated a recall (recall initiation 2026-08-05; reported in the FDA Enforcement Report 2026-09-09) covering 1 product listing(s). FDA's stated reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| Apollo Care, LLC | Recall | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO ; SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOL; SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOL (+8 more product listings) | Apollo Care, LLC initiated a recall (recall initiation 2026-07-29; reported in the FDA Enforcement Report 2026-08-19) covering 11 product listing(s). FDA's stated reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Form 483 | Not specified in source | FDA issued a Form FDA 483 to STAQ Pharma of Ohio, LLC, Columbus, OH (503B facility) on 2026-08-19. The form lists 3 observation(s), including: laboratory testing/release; records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Victory Medical Center Pharmacy | Recall | Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alc | Victory Medical Center Pharmacy initiated a recall (recall initiation 2026-07-01; reported in the FDA Enforcement Report 2026-08-19) covering 1 product listing(s). FDA's stated reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| Carolina Infusion, Ridgeland, SC | Form 483 | Tirzepatide, Testosterone, Cyanocobalamin | FDA issued a Form FDA 483 to Carolina Infusion, Ridgeland, SC (503A facility) on 2026-08-18, listing inspectional observations from an inspection dated 8/5/2026-8/18/2026. The form lists 10 observation(s), including: cleaning/disinfection; released product with strength/quality below label; airflow (smoke) studies; facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Central Admixture Pharmacy Services Inc | Recall | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL | Central Admixture Pharmacy Services Inc initiated a recall (recall initiation 2026-07-16; reported in the FDA Enforcement Report 2026-08-12) covering 1 product listing(s). FDA's stated reason: Incorrect Product Formulation. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| QuVa Pharma, Inc. | Recall | Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 | QuVa Pharma, Inc. initiated a recall (recall initiation 2026-06-24; reported in the FDA Enforcement Report 2026-07-15) covering 1 product listing(s). FDA's stated reason: Failed Impurities/Degradation Specifications. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Central Admixture Pharmacy Services, Inc. | Recall | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compou | Central Admixture Pharmacy Services, Inc. initiated a recall (recall initiation 2026-06-02; reported in the FDA Enforcement Report 2026-07-01) covering 1 product listing(s). FDA's stated reason: Incorrect product formulation: bag did not contain copper and famotidine per label. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| IntegraDose Compounding Services LLC | Recall | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victori | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2026-05-18; reported in the FDA Enforcement Report 2026-06-24) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Annovex Pharma, Inc., Lorton, VA | Form 483 | Not specified in source | FDA issued an amended Form FDA 483 to Annovex Pharma, Inc., Lorton, VA (503B facility) on 2026-06-18, listing inspectional observations from an inspection dated 5/27/2026-6/3/2026. The form lists 2 observation(s), including: equipment design/maintenance; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fayetteville VA Medical Center. Fayetteville, NC | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Fayetteville VA Medical Center. Fayetteville, NC (503A facility) on 2026-06-15. The form lists 3 observation(s), including: microbial contamination in controlled areas; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Denver Solutions, LLC (dba Leiter's Health), Englewood, CO | Other | Bevacizumab | FDA issued an Untitled Letter to Denver Solutions, LLC (dba Leiter's Health), Englewood, CO dated 2026-06-08 following an inspection from November 13, 2025 to December 11, 2025 (Form FDA 483 issued December 11, 2025). The letter states investigators noted deficiencies in drug production practices.Status: Listed | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Form 483 | Progesterone | FDA issued a Form FDA 483 to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL (503B facility) on 2026-05-29, listing inspectional observations from an inspection dated 05/18/2026-05/29/2026. The form lists 7 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; quality control unit responsibilities; production and process controls. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| IntegraDose Compounding Services LLC | Recall | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Servic | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2026-05-12; reported in the FDA Enforcement Report 2026-05-27) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles | Recall | TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injectio | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles initiated a recall (recall initiation 2025-12-27; reported in the FDA Enforcement Report 2026-05-13) covering 1 product listing(s). FDA's stated reason: Incorrect Product Formulation: product did not contain insulin as listed in the label. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Other | Not specified in source | FDA issued a close-out letter on 2026-05-13 for Warning Letter 639220 (issued 2022-08-29 to Vita Pharmacy LLC dba Talon Pharmacy of Boerne; FDA's close-out page is titled Strive Pharmacy Texas LLC). FDA lists it under Vita Pharmacy dba Talon Compounding Pharmacy, San Antonio, TX.Status: Closed out | FDA record | |
| Richmond VA Medical Center, Richmond, VA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Richmond VA Medical Center, Richmond, VA (503A facility) on 2026-05-12. The form lists 8 observation(s), including: ISO 5 area practices; personnel practices; cleaning/disinfection; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| VA San Diego Healthcare Systems, San Diego, CA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to VA San Diego Healthcare Systems, San Diego, CA (503A facility) on 2026-05-08. The form lists 11 observation(s), including: airflow (smoke) studies; cleaning/disinfection; microbial contamination in controlled areas; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Turbare Manufacturing, Conway, AR | Form 483 | Not specified in source | FDA issued an amended Form FDA 483 to Turbare Manufacturing, Conway, AR (503B facility) on 2026-05-07. The form lists 4 observation(s), including: quality control unit responsibilities; procedures to prevent microbial contamination of sterile products; personnel practices; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Wells Pharma of Houston LLC | Recall | Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03; fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma; fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 25 (+4 more product listings) | Wells Pharma of Houston LLC initiated a recall (recall initiation 2026-04-01; reported in the FDA Enforcement Report 2026-05-06) covering 7 product listing(s). FDA's stated reason: cGMP deviations. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| QuVa Pharma, Inc. Sugar Land, TX | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to QuVa Pharma, Inc. Sugar Land, TX on 2026-05-05. The letter itself is not linked on the page.Status: Listed | FDA record | |
| QuVa Pharma, Inc. Sugar Land, TX | Form 483 | Fentanyl | FDA issued a Form FDA 483 to QuVa Pharma, Inc. Sugar Land, TX (503B facility) on 2026-05-04, listing inspectional observations from an inspection dated 4/20/2026-5/4/2026. The form lists 3 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Nephron SC, LLC | Recall | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, | Nephron SC, LLC initiated a recall (recall initiation 2026-03-17; reported in the FDA Enforcement Report 2026-04-22) covering 1 product listing(s). FDA's stated reason: Labelling: Illegible label. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| PAYLESS COMPOUNDERS, LLC | Recall | Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compoun | PAYLESS COMPOUNDERS, LLC initiated a recall (recall initiation 2026-03-06; reported in the FDA Enforcement Report 2026-04-22) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL on 2026-04-22. The letter itself is not linked on the page.Status: Listed | FDA record | |
| BPI Labs, LLC, Largo, FL | Form 483 | Tirzepatide, Testosterone, Pyridoxine | FDA issued a Form FDA 483 to BPI Labs, LLC, Largo, FL (503B facility) on 2026-04-17. The form lists 4 observation(s), including: bulk drug substances not eligible under 503B; quality control unit responsibilities; stability testing program; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Central Alabama Veterans Health Care System-West Campus, Montgomery, AL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Central Alabama Veterans Health Care System-West Campus, Montgomery, AL (503A facility) on 2026-04-16. The form lists 8 observation(s), including: media fills; airflow (smoke) studies; cleaning/disinfection; environmental monitoring. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services | Recall | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34t; norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34; Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 (+2 more product listings) | Fagron Compounding Services initiated a recall (recall initiation 2026-03-20; reported in the FDA Enforcement Report 2026-04-15) covering 5 product listing(s). FDA's stated reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Wells Pharma of Houston LLC, Houston, TX | Form 483 | Not specified in source | FDA issued an amended Form FDA 483 to Wells Pharma of Houston LLC, Houston, TX (503B facility) on 2026-04-14. The form lists 6 observation(s), including: procedures to prevent microbial contamination of sterile products; laboratory testing/release; stability testing program; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to STAQ Pharma of Ohio, LLC, Columbus, OH on 2026-04-09. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Wells Pharmacy Network LLC, Dyersburg, TN | Form 483 | Testosterone, Progesterone, Estradiol | FDA issued a Form FDA 483 to Wells Pharmacy Network LLC, Dyersburg, TN (503B facility) on 2026-04-09, listing inspectional observations from an inspection dated 4/6/2026-4/9/2026. The form lists 2 observation(s), including: production and process controls; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Molecular PharmaGroup, LLC, New Providence, NJ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Molecular PharmaGroup, LLC, New Providence, NJ on 2026-04-08. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Pharmaneek Inc., Indianapolis, IN | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Pharmaneek Inc., Indianapolis, IN (503B facility) on 2026-04-08, listing inspectional observations from an inspection dated 03/30/2026-04/08/2026. The form lists 3 observation(s), including: cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| ProRX LLC, Exton, PA | Warning Letter | Semaglutide, Tirzepatide, Glutathione | Following a 2025-09-09 to 2025-09-19 inspection of ProRx LLC (503B, Exton, PA), FDA issued a Warning Letter citing compounding with tirzepatide bulk substance (not on the 503B bulks list and not compounded under a drug-shortage listing), missing label statements on NAD+, glutathione and tirzepatide products, and aseptic-practice deficiencies. It acknowledges a 2025-10-15 recall of tirzepatide and semaglutide multidose vials for lack of sterility assurance.Status: Issued | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, Sermorelin, Tesamorelin, NAD+, Gonadorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2026-03-27, listing inspectional observations from an inspection dated 3/9/2026-3/27/2026. The form lists 5 observation(s), including: microbial contamination in controlled areas; personnel practices; airflow (smoke) studies; ISO 5 area practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to IntegraDose Compounding Services, LLC, Minneapolis, MN on 2026-03-26. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Wells Pharmacy Network LLC, Dyersburg, TN | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Wells Pharmacy Network LLC, Dyersburg, TN on 2026-03-26. The letter itself is not linked on the page.Status: Listed | FDA record | |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to IntegraDose Compounding Services, LLC, Minneapolis, MN on 2026-03-25. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Other | Not specified in source | FDA issued a close-out letter for Warning Letter 703497 (issued 2025-04-08) to Tailstorm Health dba Medivant Health, stating it appears the firm adequately addressed the violations. The close-out does not preclude future regulatory action.Status: Closed out | FDA record | |
| RC Outsourcing LLC, Lowellville, OH | Warning Letter | Bevacizumab | Following a 2025-08-18 to 2025-08-28 inspection of RC Outsourcing (503B, Lowellville, OH), FDA issued a Warning Letter citing exposure of sterile materials to lower-than-ISO 5 air, inadequate investigations, environmental monitoring and component identity testing, and unapproved/misbranded repackaged products (e.g., bevacizumab, povidone-iodine). It acknowledges a 2025-09-22 recall of four bevacizumab lots.Status: Issued | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Tailstorm Health, Inc., Phoenix, AZ on 2026-03-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Tailstorm Health, Inc., Phoenix, AZ on 2026-03-19. The letter itself is not linked on the page.Status: Listed | FDA record | |
| SCA Pharmaceuticals, LLC., Windsor, CT | Form 483 | Oxytocin, Fentanyl | FDA issued a Form FDA 483 to SCA Pharmaceuticals, LLC., Windsor, CT (503B facility) on 2026-03-13. The form lists 3 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL | Form 483 | Oxytocin, Fentanyl | FDA issued a Form FDA 483 to Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL (503B facility) on 2026-03-12, listing inspectional observations from an inspection dated 2/17/2026-3/12/2026. The form lists 9 observation(s), including: cleaning/disinfection; production and process controls; quality control unit responsibilities; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| New Life Pharma LLC | Recall | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, K; Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, ; Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66 (+1 more product listings) | New Life Pharma LLC initiated a recall (recall initiation 2026-02-26; reported in the FDA Enforcement Report 2026-03-11) covering 4 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| F.H. INVESTMENTS, Inc. (dba Asteria Health) | Recall | ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.; ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32; ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012- (+22 more product listings) | F.H. INVESTMENTS, Inc. (dba Asteria Health) initiated a recall (recall initiation 2026-01-26; reported in the FDA Enforcement Report 2026-02-18) covering 25 product listing(s). FDA's stated reason: Presence of Foreign substance - potential presence of metal particulate matter. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Fresenius Kabi Compounding, LLC | Recall | acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Sin; ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Servic; thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 (+2 more product listings) | Fresenius Kabi Compounding, LLC initiated a recall (recall initiation 2026-02-05; reported in the FDA Enforcement Report 2026-02-18) covering 5 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Thrive Health and Wellness, LLC, dba Thrive Health Solutions, Englewood, CO | Warning Letter | Tirzepatide, NAD+, Cyanocobalamin | Following a 2025-03-25 to 2025-04-03 inspection of Thrive Health and Wellness dba Thrive Health Solutions (503A repackager, Englewood, CO), FDA issued a Warning Letter citing aseptic operations outside an ISO 5 area, no media fills, and unapproved/misbranded repackaged products including NAD+ 50 mg/mL and tirzepatide/cyanocobalamin injections. It acknowledges a 2025-05-21 recall of repackaged sterile products.Status: Issued | FDA record | |
| Molecular PharmaGroup, LLC, New Providence, NJ | Other | Not specified in source | FDA issued an Untitled Letter to Molecular PharmaGroup, LLC, New Providence, NJ dated 2026-02-05 following an inspection from July 28, 2025 to August 11, 2025 (Form FDA 483 issued August 11, 2025). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| Apollo Care LLC, Columbia, MO | Warning Letter | Fentanyl | Following a 2025-03-10 to 2025-03-27 inspection of Apollo Care (503B, Columbia, MO), FDA issued a Warning Letter citing inadequate segregation of sanitizing agents from bulk drug solution, microbial contamination without adequate evaluation, foreign matter and hard-to-clean surfaces. It acknowledges a 2025-04-15 recall of a fentanyl/ropivacaine epidural product for lack of sterility assurance.Status: Issued | FDA record | |
| North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX on 2026-01-30. The letter itself is not linked on the page.Status: Listed | FDA record | |
| North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX | Other | Not specified in source | FDA issued a close-out letter on 2026-01-27 for Warning Letter 642792 to North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding (503A, Richardson, TX).Status: Closed out | FDA record | |
| GenoGenix, LLC, Boca Raton, FL | Warning Letter | Semaglutide, Tirzepatide, NAD+, Glutathione | Following a 2025-07-14 to 2025-07-18 inspection of GenoGenix LLC (503B, Boca Raton, FL), FDA issued a Warning Letter citing compounding from bulk substances ineligible under 503B (5-amino-1MQ and NAD+), missing label statements (e.g., glutathione magnesium, epithalon), adverse-event and product-report failures, and sterile-processing deficiencies. It acknowledges a 2025-07-30 recall.Status: Issued | FDA record | |
| Boothwyn Pharmacy LLC, Kennett Square, PA | Warning Letter | Semaglutide, Tirzepatide | Following a 2025-05-12 to 2025-06-09 inspection of Boothwyn Pharmacy (503A, Kennett Square, PA), FDA issued a Warning Letter citing repeat smoke-study deficiencies, hard-to-clean production surfaces and release of subpotent products, including semaglutide 2.5 mg/mL (79.9% potency) and tirzepatide 10 mg/mL (86.8% and 89.1%). It acknowledges a 2025-07-09 recall of out-of-specification lots.Status: Issued | FDA record | |
| Imprimis NJOF, LLC | Recall | Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledg; Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimi; Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis N | Imprimis NJOF, LLC initiated a recall (recall initiation 2025-12-18; reported in the FDA Enforcement Report 2026-01-14) covering 3 product listing(s). FDA's stated reason: Presence of particulate matter - Glass like particles. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| US Specialty Formulations LLC, Allentown, PA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to US Specialty Formulations LLC, Allentown, PA (503B facility) on 2026-01-14. The form lists 7 observation(s), including: stability testing program; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Wedgewood Connect, LLC, San Jose, CA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Wedgewood Connect, LLC, San Jose, CA on 2026-01-02. The letter itself is not linked on the page.Status: Listed | FDA record |
2025 119
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| FH Investments Inc., (dba Asteria Health), Birmingham, AL | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to FH Investments Inc., (dba Asteria Health), Birmingham, AL (503B facility) on 2025-12-19. The form lists 10 observation(s), including: production and process controls; procedures to prevent microbial contamination of sterile products; quality control unit responsibilities; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services | Recall | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-U | Fagron Compounding Services initiated a recall (recall initiation 2025-11-20; reported in the FDA Enforcement Report 2025-12-17) covering 1 product listing(s). FDA's stated reason: Incorrect Product Formulation. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| MedisourceRx, Los Alamitos, CA | Warning Letter | Not specified in source | Following a 2025-05-27 to 2025-06-10 inspection of MedisourceRx (503B, Los Alamitos, CA), FDA issued a Warning Letter citing a failure to submit an adverse event report (complaint C25004) and adverse-event procedures that do not define a 'serious' adverse event.Status: Issued | FDA record | |
| Denver Solutions, LLC (dba Leiter's Health), Englewood, CO | Form 483 | Bevacizumab | FDA issued a Form FDA 483 to Denver Solutions, LLC (dba Leiter's Health), Englewood, CO (503B facility) on 2025-12-11. The form lists 7 observation(s), including: production and process controls; equipment design/maintenance; cleaning/disinfection; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Nubratori Inc. dba Nubratori Rx, Torrance, CA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Nubratori Inc. dba Nubratori Rx, Torrance, CA (503B facility) on 2025-12-11, listing inspectional observations from an inspection dated 12/1/2025-12/11/2025. The form lists 3 observation(s), including: cleaning/disinfection; production and process controls; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Park Avenue Compounding | Recall | Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Sain | Park Avenue Compounding initiated a recall (recall initiation 2025-09-17; reported in the FDA Enforcement Report 2025-12-10) covering 1 product listing(s). FDA's stated reason: CGMP Deviations. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Other | Not specified in source | FDA issued an Untitled Letter to STAQ Pharma of Ohio, LLC, Columbus, OH dated 2025-12-05 following an inspection from May 6, 2025 to May 16, 2025 (Form FDA 483 issued May 16, 2025). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| Imprimis NJOF, LLC | Recall | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, | Imprimis NJOF, LLC initiated a recall (recall initiation 2025-10-20; reported in the FDA Enforcement Report 2025-11-26) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| Park Avenue Compounding | Recall | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compoundi | Park Avenue Compounding initiated a recall (recall initiation 2025-09-23; reported in the FDA Enforcement Report 2025-11-26) covering 1 product listing(s). FDA's stated reason: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Delta Pharma, Inc., Ripley, MS | Form 483 | Semaglutide | FDA issued a Form FDA 483 to Delta Pharma, Inc., Ripley, MS (503B facility) on 2025-11-21. The form lists 2 observation(s), including: labeling required of outsourcing facilities; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| LeeSar, Inc., Fort Myers, FL | Other | Not specified in source | FDA issued an Untitled Letter to LeeSar, Inc., Fort Myers, FL dated 2025-11-21 following an inspection from April 29, 2025 to May 9, 2025 (Form FDA 483 issued May 9, 2025). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL on 2025-11-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Semaglutide, Glutathione, Testosterone, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2025-11-14. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; cleaning/disinfection; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Tirzepatide, Testosterone | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2025-11-14. The form lists 6 observation(s), including: microbial contamination in controlled areas; cleaning/disinfection; personnel practices; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| OSRX, Inc., Missoula, MT | Form 483 | Not specified in source | FDA issued a Form FDA 483 to OSRX, Inc., Missoula, MT (503B facility) on 2025-11-14. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; records; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Pine Pharmaceuticals, Tonawanda, NY | Form 483 | Bevacizumab | FDA issued a Form FDA 483 to Pine Pharmaceuticals, Tonawanda, NY (503B facility) on 2025-11-14. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Form 483 | Semaglutide, Bevacizumab | FDA issued a Form FDA 483 to Tailstorm Health, Inc., Phoenix, AZ (503B facility) on 2025-11-14. The form lists 3 observation(s), including: laboratory testing/release; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Wells Pharma of Houston LLC, Houston, TX | Warning Letter | Fentanyl | Following a 2025-03-17 to 2025-03-28 inspection of Wells Pharma of Houston (503B, Houston, TX), FDA issued a Warning Letter citing label omissions (e.g., fentanyl and phenylephrine in saline), adverse-event reporting failures, media fills not under worst-case conditions, inadequate smoke studies and damaged ISO 5 equipment.Status: Issued | FDA record | |
| FARMAKEIO OUTSOURCING LLC | Recall | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimbal; Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimbal; Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kim (+12 more product listings) | FARMAKEIO OUTSOURCING LLC initiated a recall (recall initiation 2025-10-14; reported in the FDA Enforcement Report 2025-11-05) covering 15 product listing(s). FDA's stated reason: CGMP Deviations: Potential presence of metal particulate matter. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Fresenius Kabi Compounding, LLC, Canton, MA | Form 483 | Oxytocin | FDA issued a Form FDA 483 to Fresenius Kabi Compounding, LLC, Canton, MA (503B facility) on 2025-11-05, listing inspectional observations from an inspection dated 10/9/2025-11/5/2025. The form lists 7 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; quality control unit responsibilities; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| ProRx LLC | Recall | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx,; Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProR; Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: Pro (+4 more product listings) | ProRx LLC initiated a recall (recall initiation 2025-10-15; reported in the FDA Enforcement Report 2025-11-05) covering 7 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| QuVa Pharma, Inc. | Recall | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution | QuVa Pharma, Inc. initiated a recall (recall initiation 2025-10-10; reported in the FDA Enforcement Report 2025-11-05) covering 1 product listing(s). FDA's stated reason: Presence of Particulate Matter. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| SCA Pharmaceuticals, LLC, Little Rock, AR | Form 483 | Ketamine | FDA issued a Form FDA 483 to SCA Pharmaceuticals, LLC, Little Rock, AR (503B facility) on 2025-10-30. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| IntegraDose Compounding Services LLC | Recall | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Service | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2025-09-16; reported in the FDA Enforcement Report 2025-10-22) covering 1 product listing(s). FDA's stated reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| STAQ Pharma, Inc. | Recall | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14; Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42; FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 1 | STAQ Pharma, Inc. initiated a recall (recall initiation 2025-10-09; reported in the FDA Enforcement Report 2025-10-22) covering 3 product listing(s). FDA's stated reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| GenoGenix LLC | Recall | Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca; Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton; Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2 (+54 more product listings) | GenoGenix LLC initiated a recall (recall initiation 2025-07-30; reported in the FDA Enforcement Report 2025-10-15) covering 57 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class I, Class II; status: Ongoing.Class I, Class II · Status: Ongoing | FDA record | |
| RC Outsourcing, LLC | Recall | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Us | RC Outsourcing, LLC initiated a recall (recall initiation 2025-09-22; reported in the FDA Enforcement Report 2025-10-15) covering 1 product listing(s). FDA's stated reason: Lack of assurance of sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Wells Pharmacy Network LLC, Dyersburg, TN | Other | Not specified in source | FDA issued an Untitled Letter to Wells Pharmacy Network LLC, Dyersburg, TN dated 2025-10-14 following an inspection from April 14, 2025 to April 25, 2025 (Form FDA 483 issued April 25, 2025). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| East Orange VA Medical Center, East Orange, NJ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to East Orange VA Medical Center, East Orange, NJ on 2025-09-24. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Fagron Compounding Services | Recall | bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Ser | Fagron Compounding Services initiated a recall (recall initiation 2025-08-29; reported in the FDA Enforcement Report 2025-09-24) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Park Avenue Compounding. Saint Louis, MO | Form 483 | Oxytocin, Fentanyl | FDA issued an amended Form FDA 483 to Park Avenue Compounding. Saint Louis, MO (503B facility) on 2025-09-23. The form lists 8 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; quality control unit responsibilities; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2025-01-27 to 2025-02-07 inspection of Revive Rx Pharmacy (503A, Houston, TX), FDA issued a Warning Letter citing insanitary sterile-processing conditions: exposure of sterile product to worse-than-specified air quality, microbial contamination without adequate evaluation, media fills not under worst-case conditions, inadequate smoke studies and sterilization/environmental-monitoring gaps.Status: Issued | FDA record | |
| ProRX LLC, Exton, PA | Form 483 | Semaglutide, Tirzepatide, NAD+, Glutathione | FDA issued a Form FDA 483 to ProRX LLC, Exton, PA (503B facility) on 2025-09-19. The form lists 7 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; laboratory testing/release; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Other | Not specified in source | FDA issued an Untitled Letter to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL dated 2025-09-16 following an inspection from February 13, 2025 to March 6, 2025 (Form FDA 483 issued March 6, 2025). The letter states investigators noted deficiencies in drug production practices.Status: Listed | FDA record | |
| Turbare Manufacturing, Conway, AR | Warning Letter | Bevacizumab | Following a 2025-01-14 to 2025-01-24 inspection of Turbare Manufacturing (503B, Conway, AR), FDA issued a Warning Letter citing media fills not under worst-case conditions, inadequate investigations of discrepancies, quality-control acceptance criteria and environmental monitoring. It acknowledges a 2025-02-18 recall of two lots of bevacizumab 1.25 mg/0.05 mL syringes.Status: Issued | FDA record | |
| Boothwyn Pharmacy LLC | Recall | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy; Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496; Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy (+1 more product listings) | Boothwyn Pharmacy LLC initiated a recall (recall initiation 2025-07-09; reported in the FDA Enforcement Report 2025-09-10) covering 4 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class II, Class III; status: Ongoing.Class II, Class III · Status: Ongoing | FDA record | |
| Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA | Form 483 | Oxytocin | FDA issued an amended Form FDA 483 to Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA (503B facility) on 2025-09-05. The form lists 5 observation(s), including: procedures to prevent microbial contamination of sterile products; laboratory testing/release; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Central Admixture Pharmacy Services, Inc., Phoenix, AZ | Form 483 | Oxytocin | FDA issued a Form FDA 483 to Central Admixture Pharmacy Services, Inc., Phoenix, AZ (503B facility) on 2025-09-05, listing inspectional observations from an inspection dated 8/18/2025-9/5/2025. The form lists 8 observation(s), including: investigation of discrepancies and failed batches; laboratory testing/release; quality control unit responsibilities; component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Farmakeio Outsourcing LLC, Southlake, TX | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Farmakeio Outsourcing LLC, Southlake, TX (503B facility) on 2025-09-05, listing inspectional observations from an inspection dated 8/18/2025-9/5/2025. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; laboratory testing/release; equipment design/maintenance. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX | Form 483 | Pyridoxine | FDA issued a Form FDA 483 to North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding), Richardson, TX (503A facility) on 2025-09-05. The form lists 1 observation(s), including: cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Qualgen LLC, Edmond, OK | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Qualgen LLC, Edmond, OK (503B facility) on 2025-09-04. The form lists 5 observation(s), including: quality control unit responsibilities; procedures to prevent microbial contamination of sterile products; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| RC Outsourcing LLC, Lowellville, OH | Form 483 | Bevacizumab | FDA issued a Form FDA 483 to RC Outsourcing LLC, Lowellville, OH (503B facility) on 2025-08-28, listing inspectional observations from an inspection dated 8/18/2025-8/28/2025. The form lists 8 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; laboratory testing/release; equipment design/maintenance. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Eagle Pharmacy, Inc., Hoover, AL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Eagle Pharmacy, Inc., Hoover, AL on 2025-08-25. The letter itself is not linked on the page.Status: Listed | FDA record | |
| AEQUITA PHARMACY | Recall | Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneous; Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, S; Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, S (+10 more product listings) | AEQUITA PHARMACY initiated a recall (recall initiation 2025-07-18; reported in the FDA Enforcement Report 2025-08-13) covering 13 product listing(s). FDA's stated reason: Lack of Processing Controls. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Molecular PharmaGroup, LLC, New Providence, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Molecular PharmaGroup, LLC, New Providence, NJ (503B facility) on 2025-08-11, listing inspectional observations from an inspection dated 7/28/2025-8/11/2025. The form lists 3 observation(s), including: equipment design/maintenance; procedures to prevent microbial contamination of sterile products; records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Anazaohealth Corporation, Las Vegas, NV | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Anazaohealth Corporation, Las Vegas, NV (503B facility) on 2025-08-08. The form lists 4 observation(s), including: production and process controls; procedures to prevent microbial contamination of sterile products; complaint records; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS | Form 483 | Oxytocin | FDA issued a Form FDA 483 to Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS (503B facility) on 2025-08-08. The form lists 6 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; facility design; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Hikma Injectables USA Inc., Dayton, NJ | Form 483 | Ketamine | FDA issued a Form FDA 483 to Hikma Injectables USA Inc., Dayton, NJ (503B facility) on 2025-08-08. The form lists 4 observation(s), including: production and process controls; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL | Form 483 | Not specified in source | FDA issued an amended Form FDA 483 to OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL (503B facility) on 2025-08-08. The form lists 3 observation(s), including: procedures to prevent microbial contamination of sterile products; production and process controls; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Imprimis NJOF, LLC | Recall | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Rou; Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML v | Imprimis NJOF, LLC initiated a recall (recall initiation 2025-07-09; reported in the FDA Enforcement Report 2025-07-30) covering 2 product listing(s). FDA's stated reason: Sub-Potent Drug: Subpotent assay results during stability testing. Classification: Class II, Class III; status: Completed.Class II, Class III · Status: Completed | FDA record | |
| Delta Pharma, Inc., Ripley, MS | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Delta Pharma, Inc., Ripley, MS on 2025-07-29. The letter itself is not linked on the page.Status: Listed | FDA record | |
| BPI Labs, LLC, Largo, FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to BPI Labs, LLC, Largo, FL on 2025-07-28. The letter itself is not linked on the page.Status: Listed | FDA record | |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Form 483 | Oxytocin, Fentanyl | FDA issued a Form FDA 483 to IntegraDose Compounding Services, LLC, Minneapolis, MN (503B facility) on 2025-07-25. The form lists 6 observation(s), including: procedures to prevent microbial contamination of sterile products; personnel practices; equipment design/maintenance; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles | Recall | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles initiated a recall (recall initiation 2025-07-01; reported in the FDA Enforcement Report 2025-07-23) covering 1 product listing(s). FDA's stated reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Qualgen, LLC | Recall | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Par | Qualgen, LLC initiated a recall (recall initiation 2025-06-16; reported in the FDA Enforcement Report 2025-07-23) covering 1 product listing(s). FDA's stated reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| GenoGenix, LLC, Boca Raton, FL | Form 483 | Semaglutide, Tirzepatide, NAD+, NAD, Glutathione, Oxytocin | FDA issued an amended Form FDA 483 to GenoGenix, LLC, Boca Raton, FL (503B facility) on 2025-07-18. The form lists 16 observation(s), including: procedures to prevent microbial contamination of sterile products; quality control unit responsibilities; investigation of discrepancies and failed batches; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX | Form 483 | Testosterone | FDA issued a Form FDA 483 to Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX (503B facility) on 2025-07-18, listing inspectional observations from an inspection dated 7/7/2025-7/18/2025. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; equipment design/maintenance; records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO | Form 483 | Testosterone, Progesterone, Estradiol | FDA issued an amended Form FDA 483 to BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO (503B facility) on 2025-07-16. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; personnel practices; production and process controls; stability testing program. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Tailstorm Health INC | Recall | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltra; BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Sing; KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Do (+3 more product listings) | Tailstorm Health INC initiated a recall (recall initiation 2025-06-02; reported in the FDA Enforcement Report 2025-07-09) covering 6 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Wedgewood Connect, LLC, San Jose, CA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Wedgewood Connect, LLC, San Jose, CA (503B facility) on 2025-07-03. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Exela Pharma Sciences, LLC, Lenoir, NC | Warning Letter | Fentanyl | Following a 2024-11-04 to 2024-11-15 CGMP inspection of Exela Pharma Sciences (Lenoir, NC; listed by FDA as a 503B facility later de-registered), FDA issued a Warning Letter citing invalidated out-of-specification particulate results for sodium bicarbonate injection, laboratory-record deficiencies and sterility-testing and stability-program gaps.Status: Issued | FDA record | |
| Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) | Recall | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A; CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, ; LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanoc (+11 more product listings) | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) initiated a recall (recall initiation 2025-05-21; reported in the FDA Enforcement Report 2025-07-02) covering 14 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| BSO LLC (dba Belmar Select Outsourcing), Golden, CO | Form 483 | Estradiol | FDA issued a Form FDA 483 to BSO LLC (dba Belmar Select Outsourcing), Golden, CO (503B facility) on 2025-06-27. The form lists 8 observation(s), including: procedures to prevent microbial contamination of sterile products; production and process controls; stability testing program; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| OurPharma LLC, Fayetteville, AR | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to OurPharma LLC, Fayetteville, AR on 2025-06-23. The letter itself is not linked on the page.Status: Listed | FDA record | |
| QuVa Pharma, Inc. Sugar Land, TX | Other | Fentanyl | FDA issued an Untitled Letter to QuVa Pharma, Inc. Sugar Land, TX dated 2025-06-18 following an inspection from September 24, 2024 to October 28, 2024 (Form FDA 483 issued October 28, 2024). The letter states investigators noted deficiencies in drug production practices. It acknowledges a firm-initiated voluntary recall.Status: Listed | FDA record | |
| Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL | Form 483 | NAD+, Testosterone | FDA issued a Form FDA 483 to Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL (503A facility) on 2025-06-13, listing inspectional observations from an inspection dated 6/3/2025-6/13/2025. The form lists 2 observation(s), including: ISO 5 area practices; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Overton Brooks VA Medical Center, Shreveport, LA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Overton Brooks VA Medical Center, Shreveport, LA on 2025-06-11. The letter itself is not linked on the page.Status: Listed | FDA record | |
| MedisourceRx, Los Alamitos, CA | Form 483 | Semaglutide | FDA issued a Form FDA 483 to MedisourceRx, Los Alamitos, CA (503B facility) on 2025-06-10, listing inspectional observations from an inspection dated 5/27/2025-6/10/2025. The form lists 2 observation(s), including: facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Boothwyn Pharmacy LLC, Kennett Square, PA | Form 483 | Semaglutide, Tirzepatide | FDA issued a Form FDA 483 to Boothwyn Pharmacy LLC, Kennett Square, PA (503A facility) on 2025-06-09, listing inspectional observations from an inspection dated 05/12/2025-06/09/2025. The form lists 6 observation(s), including: released product with strength/quality below label; ISO 5 area practices; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC | Form 483 | Fentanyl | FDA issued a Form FDA 483 to Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC (503B facility) on 2025-06-06. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; laboratory testing/release; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| STAQ Pharma, Inc., Denver, CO | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to STAQ Pharma, Inc., Denver, CO on 2025-06-06. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX on 2025-06-05. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL on 2025-06-04. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ (503B facility) on 2025-05-23. The form lists 5 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; production and process controls; stability testing program. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Tailstorm Health, Inc., Chandler, AZ | Form 483 | Ketamine | FDA issued a Form FDA 483 to Tailstorm Health, Inc., Chandler, AZ (503B facility) on 2025-05-23. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; quality control unit responsibilities; equipment design/maintenance; facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC dba Empower PharmacyOn AffinityRx | Recall | Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Em | Empower Clinic Services, LLC dba Empower Pharmacy initiated a recall (recall initiation 2025-05-02; reported in the FDA Enforcement Report 2025-05-21) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Form 483 | Not specified in source | FDA issued a Form FDA 483 to STAQ Pharma of Ohio, LLC, Columbus, OH (503B facility) on 2025-05-16. The form lists 3 observation(s), including: investigation of discrepancies and failed batches; production and process controls; labeling required of outsourcing facilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Apollo Care, LLC | Recall | FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (Fo | Apollo Care, LLC initiated a recall (recall initiation 2025-04-15; reported in the FDA Enforcement Report 2025-05-14) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| BSO LLC | Recall | TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug,; TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug,; TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded (+2 more product listings) | BSO LLC initiated a recall (recall initiation 2025-04-28; reported in the FDA Enforcement Report 2025-05-14) covering 5 product listing(s). FDA's stated reason: Presence of Particulate Matter: Glass particles were found in pellet vials. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to John L. McClellan Memorial Veterans Hospital, Little Rock, AR on 2025-05-12. The letter itself is not linked on the page.Status: Listed | FDA record | |
| LeeSar, Inc., Fort Myers, FL | Form 483 | Oxytocin | FDA issued a Form FDA 483 to LeeSar, Inc., Fort Myers, FL (503B facility) on 2025-05-09, listing inspectional observations from an inspection dated 4/29/2025-5/9/2025. The form lists 4 observation(s), including: investigation of discrepancies and failed batches; laboratory testing/release; production and process controls. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| FH Investments Inc., (dba Asteria Health), Birmingham, AL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to FH Investments Inc., (dba Asteria Health), Birmingham, AL on 2025-05-08. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Nubratori, Inc | Recall | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Un | Nubratori, Inc initiated a recall (recall initiation 2025-04-15; reported in the FDA Enforcement Report 2025-05-07) covering 1 product listing(s). FDA's stated reason: Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly wi. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Denver Solutions, LLC DBA Leiters Health | Recall | Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blv; dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose; PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Lei (+2 more product listings) | Denver Solutions, LLC DBA Leiters Health initiated a recall (recall initiation 2025-03-31; reported in the FDA Enforcement Report 2025-04-30) covering 5 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: Leaking/damaged syringes. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| OurPharma LLC | Recall | HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. | OurPharma LLC initiated a recall (recall initiation 2025-04-15; reported in the FDA Enforcement Report 2025-04-30) covering 1 product listing(s). FDA's stated reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification. Classification: Class III; status: Terminated.Class III · Status: Terminated | FDA record | |
| East Orange VA Medical Center, East Orange, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to East Orange VA Medical Center, East Orange, NJ (503A facility) on 2025-04-29, listing inspectional observations from an inspection dated 4/22/2025-4/29/2025. The form lists 3 observation(s), including: cleaning/disinfection; ISO 5 area practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Wells Pharmacy Network LLC, Dyersburg, TN | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Wells Pharmacy Network LLC, Dyersburg, TN (503B facility) on 2025-04-25. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| OSRX, Inc., Missoula, MT | Warning Letter | Not specified in source | Following a 2024-10-16 to 2024-10-25 inspection of OSRX Inc (503B, Missoula, MT), FDA issued a Warning Letter citing missing label/container information on ophthalmic products, inadequate smoke studies, inadequate evaluation of ISO 5 microbial recovery and CGMP deficiencies.Status: Issued | FDA record | |
| SCA Pharmaceuticals, LLC., Windsor, CT | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to SCA Pharmaceuticals, LLC., Windsor, CT on 2025-04-17. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Imprimis NJOF, LLC | Recall | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fi | Imprimis NJOF, LLC initiated a recall (recall initiation 2025-02-24; reported in the FDA Enforcement Report 2025-04-09) covering 1 product listing(s). FDA's stated reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Warning Letter | Semaglutide, Tirzepatide, Bevacizumab | Following a 2024-09-24 to 2024-10-10 inspection of Tailstorm Health dba Medivant Health (503B, Phoenix, AZ), FDA issued a Warning Letter citing labels on semaglutide and tirzepatide injections lacking 'Office Use Only', adverse-event reporting failures, ISO 5 microbial contamination without adequate evaluation and inadequate smoke studies. It acknowledges a 2024-11-06 recall of bevacizumab (Avastin) syringes for lack of sterility assurance.Status: Issued | FDA record | |
| QuVa Pharma, Inc., Bloomsbury, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to QuVa Pharma, Inc., Bloomsbury, NJ (503B facility) on 2025-04-04. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Thrive Health and Wellness, LLC, dba Thrive Health Solutions, Englewood, CO | Form 483 | Semaglutide, Tirzepatide, Sermorelin, Cyanocobalamin | FDA issued a Form FDA 483 to Thrive Health and Wellness, LLC, dba Thrive Health Solutions, Englewood, CO (503A facility) on 2025-04-03. The form lists 6 observation(s), including: media fills; cleaning/disinfection; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Glutathione, Testosterone, Cyanocobalamin, Pyridoxine, Estradiol | Following a 2024-08-01 to 2024-08-28 inspection of Empower Pharmacy's 503B outsourcing facility (Houston, TX), FDA issued a Warning Letter citing missing label/container information (e.g., pyridoxine injection), microbial contamination in the ISO 5 area without adequate evaluation, inadequate smoke studies and CGMP violations. It acknowledges Empower's 2024-09-05 recall of pyridoxine HCl 100 mg/mL (lot 609763).Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2024-09-24 to 2024-10-04 inspection of Empower Pharmacy's 503A facility (Houston, TX), FDA issued a Warning Letter citing insanitary sterile-processing conditions: inadequate routine environmental monitoring and ISO 5 certification sampling, media fills not under worst-case conditions, and unsterilized equipment in the ISO 5 area.Status: Issued | FDA record | |
| QuVa Pharma, Inc. | Recall | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yell; fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS; fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yell | QuVa Pharma, Inc. initiated a recall (recall initiation 2025-03-06; reported in the FDA Enforcement Report 2025-04-02) covering 3 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Wells Pharma of Houston LLC, Houston, TX | Form 483 | Fentanyl, Ketamine | FDA issued a Form FDA 483 to Wells Pharma of Houston LLC, Houston, TX (503B facility) on 2025-03-28. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; quality control unit responsibilities; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Apollo Care LLC, Columbia, MO | Form 483 | Fentanyl, Ketamine | FDA issued a Form FDA 483 to Apollo Care LLC, Columbia, MO (503B facility) on 2025-03-27. The form lists 6 observation(s), including: quality control unit responsibilities; cleaning/disinfection; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX on 2025-03-26. No further detail is posted on the page.Status: Listed | FDA record | |
| Central Admixture Pharmacy Services, Inc. | Recall | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Phar | Central Admixture Pharmacy Services, Inc. initiated a recall (recall initiation 2025-02-20; reported in the FDA Enforcement Report 2025-03-19) covering 1 product listing(s). FDA's stated reason: Presence of Particulate Matter. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| Nephron Sterile Compounding Center LLC | Recall | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, | Nephron Sterile Compounding Center LLC initiated a recall (recall initiation 2025-02-10; reported in the FDA Enforcement Report 2025-03-19) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL (503B facility) on 2025-03-06. The form lists 3 observation(s), including: investigation of discrepancies and failed batches; cleaning/disinfection; labeling required of outsourcing facilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Annovex Pharma, Inc., Lorton, VA | Warning Letter | Not specified in source | Following a 2024-08-26 to 2024-09-06 inspection of Annovex Pharma (503B, Lorton, VA), FDA issued a Warning Letter citing a missed product report, adverse-event reporting failures, media fills not under worst-case conditions, inadequate smoke studies and quality-system deficiencies.Status: Issued | FDA record | |
| Turbare Manufacturing | Recall | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale | Turbare Manufacturing initiated a recall (recall initiation 2025-02-18; reported in the FDA Enforcement Report 2025-03-05) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: due to a quality control process deviation. Classification: Class II; status: Completed.Class II · Status: Completed | FDA record | |
| ProRX LLC, Exton, PA | Warning Letter | Semaglutide, Tirzepatide | Following a 2024-07-15 to 2024-08-02 inspection of ProRx LLC (503B, Exton, PA), FDA issued an (amended) Warning Letter citing use of a bulk drug substance from a non-registered establishment, missing label statements on products including semaglutide 5 mg/2 mL, tirzepatide 60 mg/3 mL and vancomycin, adverse-event reporting failures, and aseptic-practice deficiencies. It acknowledges a 2024-08-22 recall for lack of sterility assurance.Status: Issued | FDA record | |
| Palmetto Isotopes, LLC, Ridgeland, SC - Nuclear Phamacy | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Palmetto Isotopes, LLC, Ridgeland, SC - Nuclear Phamacy (503A (nuclear pharmacy) facility) on 2025-02-28. The form lists 6 observation(s), including: environmental monitoring; media fills; airflow (smoke) studies; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Eagle Pharmacy, Inc., Hoover, AL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Eagle Pharmacy, Inc., Hoover, AL (503B facility) on 2025-02-27. The form lists 5 observation(s), including: procedures to prevent microbial contamination of sterile products; personnel practices; cleaning/disinfection; equipment design/maintenance. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services | Recall | fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile | Fagron Compounding Services initiated a recall (recall initiation 2025-01-31; reported in the FDA Enforcement Report 2025-02-26) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Completed.Class II · Status: Completed | FDA record | |
| BPI Labs, LLC, Largo, FL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to BPI Labs, LLC, Largo, FL (503B facility) on 2025-02-21, listing inspectional observations from an inspection dated 2/10/2025-2/21/2025. The form lists 1 observation(s), including: labeling required of outsourcing facilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Brookfield Medical/Surgical Supply, Inc., Brookfield, CT on 2025-02-13. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, NAD+, Testosterone, Gonadorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2025-02-07. The form lists 7 observation(s), including: ISO 5 area practices; microbial contamination in controlled areas; environmental monitoring; media fills. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Jubilant DraxImage Radiopharmacies, Inc., (dba Triad Isotopes, Inc.), Kansas City, MO | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Jubilant DraxImage Radiopharmacies, Inc., (dba Triad Isotopes, Inc.), Kansas City, MO on 2025-02-04. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Belcher Pharmaceuticals LLC., Largo, FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Belcher Pharmaceuticals LLC., Largo, FL on 2025-01-29. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Vital Care of Dickson, Dickson, TN | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Vital Care of Dickson, Dickson, TN on 2025-01-27. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Carolina Infusion, Ridgeland, SC | Form 483 | Semaglutide, Testosterone, Cyanocobalamin | FDA issued a Form FDA 483 to Carolina Infusion, Ridgeland, SC (503A facility) on 2025-01-24. The form lists 6 observation(s), including: ISO 5 area practices; environmental monitoring; media fills; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Turbare Manufacturing, Conway, AR | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Turbare Manufacturing, Conway, AR (503B facility) on 2025-01-24, listing inspectional observations from an inspection dated 1/14/2025-1/24/2025. The form lists 8 observation(s), including: investigation of discrepancies and failed batches; quality control unit responsibilities; personnel practices; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Nubratori Inc. dba Nubratori Rx, Torrance, CA | Warning Letter | Not specified in source | Following a 2024-07-16 to 2024-07-26 inspection of Nubratori Inc dba Nubratori Rx (503B, Torrance, CA), FDA issued a Warning Letter citing inadequate personnel sampling, quality-unit release criteria, environmental monitoring, equipment cleaning and component microbiological testing.Status: Issued | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX on 2025-01-22. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Hikma Injectables USA Inc | Recall | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectabl; phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 | Hikma Injectables USA Inc initiated a recall (recall initiation 2024-12-19; reported in the FDA Enforcement Report 2025-01-08) covering 2 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record |
2024 97
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| SCA Pharmaceuticals, LLC., Windsor, CT | Form 483 | Oxytocin, Fentanyl | FDA issued a Form FDA 483 to SCA Pharmaceuticals, LLC., Windsor, CT (503B facility) on 2024-12-20. The form lists 7 observation(s), including: investigation of discrepancies and failed batches; production and process controls; cleaning/disinfection; records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS | Warning Letter | Fentanyl | Following a 2024-06-18 to 2024-06-28 inspection of Fagron Sterile Services (503B, Wichita, KS), FDA issued a Warning Letter citing 503B label omissions (e.g., ophthalmic combination products), insanitary sterile-production conditions and CGMP violations. It acknowledges a 2024-08-15 recall of four lots of lidocaine 2% injection for lack of sterility assurance.Status: Issued | FDA record | |
| Overton Brooks VA Medical Center, Shreveport, LA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Overton Brooks VA Medical Center, Shreveport, LA (503A facility) on 2024-12-18. The form lists 3 observation(s), including: cleaning/disinfection; media fills. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX | Warning Letter | Testosterone | Following a 2024-05-28 to 2024-06-21 inspection of Right Value Drug Stores dba Carie Boyd Pharmaceuticals (503B, Irving, TX), FDA issued a Warning Letter citing 503B label violations (e.g., ketoconazole cream and testosterone cypionate injections) and sterile-processing deficiencies (smoke studies, media fills, cleaning of equipment, environmental controls).Status: Issued | FDA record | |
| Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ on 2024-12-16. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Hikma Injectables USA Inc., Dayton, NJ | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Hikma Injectables USA Inc., Dayton, NJ on 2024-12-10. No further detail is posted on the page.Status: Listed | FDA record | |
| Tailstorm Health INC | Recall | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Med | Tailstorm Health INC initiated a recall (recall initiation 2024-11-06; reported in the FDA Enforcement Report 2024-11-27) covering 1 product listing(s). FDA's stated reason: Lack of Sterility Assurance. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Denver Solutions, LLC (dba Leiter's Health), Englewood, CO | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Denver Solutions, LLC (dba Leiter's Health), Englewood, CO on 2024-11-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Exela Pharma Sciences, LLC, Lenoir, NC | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Exela Pharma Sciences, LLC, Lenoir, NC (503B facility) on 2024-11-15. The form lists 15 observation(s), including: records; quality control unit responsibilities; procedures to prevent microbial contamination of sterile products; laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Staska Pharmaceuticals, Inc. | Recall | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, | Staska Pharmaceuticals, Inc. initiated a recall (recall initiation 2024-09-30; reported in the FDA Enforcement Report 2024-11-13) covering 1 product listing(s). FDA's stated reason: Presence of Particulate Matter: Presence of glass particulates. Classification: Class I; status: Terminated.Class I · Status: Terminated | FDA record | |
| FH Investments Inc., (dba Asteria Health), Birmingham, AL | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to FH Investments Inc., (dba Asteria Health), Birmingham, AL (503B facility) on 2024-11-08, listing inspectional observations from an inspection dated 10/28/2024-11/8/2024. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; laboratory testing/release; cleaning/disinfection; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fresenius Kabi Compounding, LLC | Recall | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Steri; Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Steri; Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Steri (+7 more product listings) | Fresenius Kabi Compounding, LLC initiated a recall (recall initiation 2024-09-25; reported in the FDA Enforcement Report 2024-10-30) covering 10 product listing(s). FDA's stated reason: CGMP violations. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| QuVa Pharma, Inc. Sugar Land, TX | Form 483 | Fentanyl | FDA issued a Form FDA 483 to QuVa Pharma, Inc. Sugar Land, TX (503B facility) on 2024-10-28. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; complaint records; quality control unit responsibilities; production and process controls. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| OSRX, Inc., Missoula, MT | Form 483 | Not specified in source | FDA issued a Form FDA 483 to OSRX, Inc., Missoula, MT (503B facility) on 2024-10-25. The form lists 6 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; laboratory testing/release; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Tailstorm Health, Inc., Phoenix, AZ | Form 483 | Semaglutide, Bevacizumab | FDA issued a Form FDA 483 to Tailstorm Health, Inc., Phoenix, AZ (503B facility) on 2024-10-10. The form lists 5 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; equipment design/maintenance; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL | Form 483 | Testosterone, Progesterone | FDA issued a Form FDA 483 to Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL (503A facility) on 2024-10-04. The form lists 2 observation(s), including: released product with strength/quality below label; microbial contamination in controlled areas. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Semaglutide, Tirzepatide, Gonadorelin | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2024-10-04. The form lists 8 observation(s), including: cleaning/disinfection; ISO 5 area practices; media fills; environmental monitoring. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower PharmacyOn AffinityRx | Recall | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX | Empower Pharmacy initiated a recall (recall initiation 2024-09-05; reported in the FDA Enforcement Report 2024-10-02) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Pine Pharmaceuticals, Tonawanda, NY | Form 483 | Bevacizumab | FDA issued a Form FDA 483 to Pine Pharmaceuticals, Tonawanda, NY (503B facility) on 2024-09-30, listing inspectional observations from an inspection dated 8/5/2024-9/30/2024. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; investigation of discrepancies and failed batches; production and process controls. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL on 2024-09-30. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | Other | Not specified in source | FDA issued an Untitled Letter to Brookfield Medical/Surgical Supply, Inc., Brookfield, CT dated 2024-09-27 following an inspection from April 22, 2024 to May 10, 2024 (Form FDA 483 issued May 10, 2024). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| OurPharma LLC, Fayetteville, AR | Form 483 | Fentanyl, Ketamine | FDA issued a Form FDA 483 to OurPharma LLC, Fayetteville, AR (503B facility) on 2024-09-27. The form lists 5 observation(s), including: production and process controls; labeling required of outsourcing facilities; product reporting to FDA. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| RC Outsourcing LLC, Lowellville, OH | Form 483 | Not specified in source | FDA issued a Form FDA 483 to RC Outsourcing LLC, Lowellville, OH (503B facility) on 2024-09-27. The form lists 8 observation(s), including: procedures to prevent microbial contamination of sterile products; laboratory testing/release; investigation of discrepancies and failed batches; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC | Form 483 | Ketamine | FDA issued a Form FDA 483 to Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC (503B facility) on 2024-09-25. The form lists 5 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Anazaohealth Corporation, Las Vegas, NV | Form 483 | Testosterone, Pyridoxine | FDA issued a Form FDA 483 to Anazaohealth Corporation, Las Vegas, NV (503B facility) on 2024-09-23. The form lists 3 observation(s), including: investigation of discrepancies and failed batches; facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Wedgewood Connect, LLC, San Jose, CA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Wedgewood Connect, LLC, San Jose, CA on 2024-09-17. The letter itself is not linked on the page.Status: Listed | FDA record | |
| ProRx LLC | Recall | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84; Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-5; SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton (+4 more product listings) | ProRx LLC initiated a recall (recall initiation 2024-08-22; reported in the FDA Enforcement Report 2024-09-11) covering 7 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Annovex Pharma, Inc., Lorton, VA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Annovex Pharma, Inc., Lorton, VA (503B facility) on 2024-09-06. The form lists 7 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; component testing/handling; records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Mark Cuban Cost Plus Manufacturing and Compounding LLC. Dallas, TX (503B facility) on 2024-09-06. The form lists 7 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; quality control unit responsibilities; facility design. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with IntegraDose Compounding Services, LLC, Minneapolis, MN on 2024-09-05. No further detail is posted on the page.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Glutathione, Testosterone, Ketamine, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2024-08-28, listing inspectional observations from an inspection dated 8/1/2024-8/28/2024. The form lists 9 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; laboratory testing/release; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services | Recall | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 871 | Fagron Compounding Services initiated a recall (recall initiation 2024-08-15; reported in the FDA Enforcement Report 2024-08-28) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Belcher Pharmaceuticals LLC., Largo, FL | Form 483 | Testosterone | FDA issued a Form FDA 483 to Belcher Pharmaceuticals LLC., Largo, FL (503B facility) on 2024-08-16. The form lists 6 observation(s), including: laboratory testing/release; labeling required of outsourcing facilities; product reporting to FDA. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| EMPOWER CLINIC SERVICES LLCOn AffinityRx | Recall | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use onl | EMPOWER CLINIC SERVICES LLC initiated a recall (recall initiation 2024-08-02; reported in the FDA Enforcement Report 2024-08-14) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL on 2024-08-14. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL | Other | Not specified in source | FDA's compounding actions page lists a letter referring Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL to its state board of pharmacy, dated 2024-08-13. See the source document for content.Status: Listed | FDA record | |
| Palisades Compounding Pharmacy, Pacific Palisades, CA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Palisades Compounding Pharmacy, Pacific Palisades, CA on 2024-08-09. The letter itself is not linked on the page.Status: Listed | FDA record | |
| SSM Health Care St. Louis, (dba SSM Health St. Clare Hospital - Fenton), Fenton, MO | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with SSM Health Care St. Louis, (dba SSM Health St. Clare Hospital - Fenton), Fenton, MO on 2024-08-08. No further detail is posted on the page.Status: Listed | FDA record | |
| ProRX LLC, Exton, PA | Form 483 | Semaglutide, Tirzepatide | FDA issued a Form FDA 483 to ProRX LLC, Exton, PA (503B facility) on 2024-08-02. The form lists 13 observation(s), including: procedures to prevent microbial contamination of sterile products; quality control unit responsibilities; investigation of discrepancies and failed batches; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Nubratori Inc. dba Nubratori Rx, Torrance, CA | Form 483 | Ketamine | FDA issued a Form FDA 483 to Nubratori Inc. dba Nubratori Rx, Torrance, CA (503B facility) on 2024-07-26. The form lists 7 observation(s), including: procedures to prevent microbial contamination of sterile products; cleaning/disinfection; component testing/handling; product reporting to FDA. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| TAILSTORM HEALTH INC | Recall | Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx | TAILSTORM HEALTH INC initiated a recall (recall initiation 2024-07-03; reported in the FDA Enforcement Report 2024-07-17) covering 1 product listing(s). FDA's stated reason: Subpotent Drug: reduced efficacy for epinephrine. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA | Warning Letter | Fentanyl, Ketamine | FDA issued a Warning Letter to Central Admixture Pharmacy Services (CAPS), San Diego, CA (503B; later de-registered). The letter acknowledges voluntary recalls of sterile products for lack of sterility assurance (2023-07-17 and 2023-09-21) and cites failures in out-of-specification investigations and sterile-processing controls.Status: Issued | FDA record | |
| BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO | Form 483 | Testosterone, Progesterone, Estradiol | FDA issued a Form FDA 483 to BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO (503B facility) on 2024-07-03. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Coast Quality Pharmacy, LLC dba Anazao Health | Recall | Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, Ana | Coast Quality Pharmacy, LLC dba Anazao Health initiated a recall (recall initiation 2024-04-24; reported in the FDA Enforcement Report 2024-07-03) covering 1 product listing(s). FDA's stated reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet. Classification: Class II; status: Completed.Class II · Status: Completed | FDA record | |
| US Specialty Formulations LLC, Allentown, PA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to US Specialty Formulations LLC, Allentown, PA (503B facility) on 2024-07-02, listing inspectional observations from an inspection dated 6/17/2024-7/2/2024. The form lists 7 observation(s), including: quality control unit responsibilities; laboratory testing/release; stability testing program; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS | Form 483 | Oxytocin, Fentanyl, Ketamine | FDA issued a Form FDA 483 to Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS (503B facility) on 2024-06-28, listing inspectional observations from an inspection dated 6/18/2024-6/28/2024. The form lists 7 observation(s), including: procedures to prevent microbial contamination of sterile products; investigation of discrepancies and failed batches; quality control unit responsibilities; complaint records. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Hikma Injectables USA Inc., Dayton, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Hikma Injectables USA Inc., Dayton, NJ (503B facility) on 2024-06-25. The form lists 4 observation(s), including: laboratory testing/release. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX (503B facility) on 2024-06-21. The form lists 6 observation(s), including: procedures to prevent microbial contamination of sterile products; equipment design/maintenance; cleaning/disinfection; labeling required of outsourcing facilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Imprimis NJOF, LLC | Recall | Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx O | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-05-14; reported in the FDA Enforcement Report 2024-06-19) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Imprimis NJOF, LLC | Recall | Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compound | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-05-14; reported in the FDA Enforcement Report 2024-06-19) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ | Form 483 | Fentanyl | FDA issued a Form FDA 483 to Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ (503B facility) on 2024-06-12. The form lists 3 observation(s), including: laboratory testing/release; quality control unit responsibilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Imprimis NJOF, LLC | Recall | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Inje; Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Inject; Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use via (+2 more product listings) | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-05-14; reported in the FDA Enforcement Report 2024-06-05) covering 5 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Imprimis NJOF, LLC | Recall | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injec | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-05-14; reported in the FDA Enforcement Report 2024-06-05) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Rev | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2024-04-20; reported in the FDA Enforcement Report 2024-06-05) covering 1 product listing(s). FDA's stated reason: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| Hikma Injectables USA Inc | Recall | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Inje | Hikma Injectables USA Inc initiated a recall (recall initiation 2024-04-29; reported in the FDA Enforcement Report 2024-05-29) covering 1 product listing(s). FDA's stated reason: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Classification: Class I; status: Completed.Class I · Status: Completed | FDA record | |
| OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL | Form 483 | Semaglutide, Tirzepatide, Glutathione, Cyanocobalamin | FDA issued a Form FDA 483 to OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL (503B facility) on 2024-05-29. The form lists 7 observation(s), including: laboratory testing/release; production and process controls; cleaning/disinfection; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| SKNV (formerly Sincerus Florida LLC), Pompano Beach FL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to SKNV (formerly Sincerus Florida LLC), Pompano Beach FL (503B facility) on 2024-05-23, listing inspectional observations from an inspection dated 5/13/2024-5/23/2024. The form lists 2 observation(s), including: labeling required of outsourcing facilities; product reporting to FDA. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Boothwyn Pharmacy LLC, Kennett Square, PA | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Boothwyn Pharmacy LLC, Kennett Square, PA on 2024-05-13. No further detail is posted on the page.Status: Listed | FDA record | |
| Brookfield Medical/Surgical Supply, Inc., Brookfield, CT | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Brookfield Medical/Surgical Supply, Inc., Brookfield, CT (503B facility) on 2024-05-10. The form lists 4 observation(s), including: procedures to prevent microbial contamination of sterile products; production and process controls; labeling required of outsourcing facilities. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Hikma Injectables USA Inc | Recall | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compound | Hikma Injectables USA Inc initiated a recall (recall initiation 2024-04-30; reported in the FDA Enforcement Report 2024-05-08) covering 1 product listing(s). FDA's stated reason: Labeling: Wrong Barcode. Classification: Class III; status: Completed.Class III · Status: Completed | FDA record | |
| Imprimis NJOF, LLC | Recall | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compou | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-04-10; reported in the FDA Enforcement Report 2024-05-08) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Imprimis NJOF, LLC | Recall | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis | Imprimis NJOF, LLC initiated a recall (recall initiation 2024-04-10; reported in the FDA Enforcement Report 2024-05-08) covering 1 product listing(s). FDA's stated reason: Out of specification for assay. Classification: Class III; status: Ongoing.Class III · Status: Ongoing | FDA record | |
| Wedgewood Connect, LLC, San Jose, CA | Other | Not specified in source | FDA issued an Untitled Letter to Wedgewood Connect, LLC, San Jose, CA dated 2024-04-25 following an inspection from November 1, 2023 to November 17, 2023 (Form FDA 483 issued November 17, 2023). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption and deficiencies in drug production practices.Status: Listed | FDA record | |
| Delta Pharma, Inc., Ripley, MS | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Delta Pharma, Inc., Ripley, MS (503B facility) on 2024-04-12, listing inspectional observations from an inspection dated 4/9/2024-4/12/2024. The form lists 3 observation(s), including: component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Northern VA Compounders PLLC, (dba Akina Pharmacy) Sterling, VA | Warning Letter | Not specified in source | Following a 2022-11-07 to 2022-12-09 inspection of Northern VA Compounders dba Akina Pharmacy (503A, Sterling, VA), FDA issued a Warning Letter citing sterile and non-sterile production deficiencies, including water quality, foreign matter, inadequate smoke studies, and use of material labeled 'research use only'. The firm recalled sterile products made from that material on 2022-12-30 for lack of sterility assurance.Status: Issued | FDA record | |
| IntegraDose Compounding Services LLC | Recall | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2024-03-22; reported in the FDA Enforcement Report 2024-04-10) covering 1 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: leaking bags. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| SSM Health Care St. Louis DBA SSM St. Clare Health Center | Recall | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use O; FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intraven | SSM Health Care St. Louis DBA SSM St. Clare Health Center initiated a recall (recall initiation 2024-02-29; reported in the FDA Enforcement Report 2024-04-10) covering 2 product listing(s). FDA's stated reason: Lack of Assurance of Sterility: Firm did not perform process validation. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| SNF Holdings, LLC, (dba Vios Compounding), Livonia, MI | Other | Not specified in source | FDA's compounding actions page lists a letter referring SNF Holdings, LLC, (dba Vios Compounding), Livonia, MI to its state board of pharmacy, dated 2024-04-09. See the source document for content.Status: Listed | FDA record | |
| Denver Solutions, LLC (dba Leiter's Health), Englewood, CO | Form 483 | Oxytocin, Bevacizumab, Fentanyl, Ketamine | FDA issued a Form FDA 483 to Denver Solutions, LLC (dba Leiter's Health), Englewood, CO (503B facility) on 2024-04-05. The form lists 7 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; quality control unit responsibilities; stability testing program. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Imprimis NJOF, LLC, Ledgewood, NJ | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Imprimis NJOF, LLC, Ledgewood, NJ (503B facility) on 2024-04-03. The form lists 5 observation(s), including: laboratory testing/release; investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| SCA Pharmaceuticals, LLC | Recall | Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Phar; fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, ; fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA (+29 more product listings) | SCA Pharmaceuticals, LLC initiated a recall (recall initiation 2023-11-09; reported in the FDA Enforcement Report 2024-04-03) covering 32 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ | Warning Letter | Not specified in source | Following a 2023-09-26 to 2023-10-25 inspection of Stokes Healthcare dba Epicur Pharma (503B, Mount Laurel, NJ), FDA issued a Warning Letter citing 503B label deficiencies (e.g., tacrolimus ophthalmic suspensions), failure to submit adverse event reports, and sterile-processing and quality-unit deficiencies (media fills, smoke studies, sporicidal contact time).Status: Issued | FDA record | |
| Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA | Warning Letter | Not specified in source | FDA issued a Warning Letter to Central Admixture Pharmacy Services (CAPS), Allentown, PA (503B). The posted letter text references the firm's 2023 inspections and acknowledges a voluntary recall of sterile drug products for lack of sterility assurance (including one initiated 2023-04-28). Letter text also cites the CAPS Phoenix inspection.Status: Issued | FDA record | |
| Central Admixture Pharmacy Services, Inc., Phoenix, AZ | Warning Letter | Oxytocin | Following a 2023-06-21 to 2023-07-31 inspection of CAPS Phoenix (503B), FDA issued a Warning Letter citing serious sterile-production deficiencies. The letter notes the firm ceased production on 2023-08-04 and distribution on 2023-07-28 and recalled sterile products for lack of sterility assurance (2023-07-14 and 2023-08-17).Status: Issued | FDA record | |
| STAQ Pharma of Ohio, LLC, Columbus, OH | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to STAQ Pharma of Ohio, LLC, Columbus, OH on 2024-03-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Qualgen LLC, Edmond, OK | Form 483 | Testosterone, Estradiol | FDA issued a Form FDA 483 to Qualgen LLC, Edmond, OK (503B facility) on 2024-03-19. The form lists 14 observation(s), including: quality control unit responsibilities; complaint records; production and process controls; procedures to prevent microbial contamination of sterile products. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Molecular PharmaGroup, LLC, New Providence, NJ | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Molecular PharmaGroup, LLC, New Providence, NJ on 2024-03-18. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Reliant Compounded Solutions Monroe, LLC. (formerly Compounded Solutions in Pharmacy, LLC), Monroe, CT | Other | Not specified in source | FDA's compounding actions page lists a letter referring Reliant Compounded Solutions Monroe, LLC. (formerly Compounded Solutions in Pharmacy, LLC), Monroe, CT to its state board of pharmacy, dated 2024-03-18. See the source document for content.Status: Listed | FDA record | |
| Reliant Compounded Solutions Monroe, LLC. (formerly Compounded Solutions in Pharmacy, LLC), Monroe, CT | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Reliant Compounded Solutions Monroe, LLC. (formerly Compounded Solutions in Pharmacy, LLC), Monroe, CT on 2024-03-18. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV | Other | Not specified in source | FDA's compounding actions page lists a letter referring Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV to its state board of pharmacy, dated 2024-03-15. See the source document for content.Status: Listed | FDA record | |
| Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV | Other | Not specified in source | FDA listed a Warning Letter close-out letter for this firm on its compounding actions page.Status: Closed out | FDA record | |
| Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV on 2024-03-15. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Pine Pharmaceuticals, Tonawanda, NY | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Pine Pharmaceuticals, Tonawanda, NY on 2024-03-14. No further detail is posted on the page.Status: Listed | FDA record | |
| A1Rx LLC (dba Rx Unlimited Pharmacy), North Hills, CA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to A1Rx LLC (dba Rx Unlimited Pharmacy), North Hills, CA on 2024-03-13. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Jubilant Draximage Radiopharmacies Inc., (dba Jubilant Radiopharma), Orlando , FL (503A (nuclear pharmacy) facility) on 2024-03-13. The form lists 6 observation(s), including: ISO 5 area practices; airflow (smoke) studies; media fills; environmental monitoring. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Denver Solutions, LLC DBA Leiters Health | Recall | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Sin; Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, ND; Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13 | Denver Solutions, LLC DBA Leiters Health initiated a recall (recall initiation 2024-02-20; reported in the FDA Enforcement Report 2024-03-06) covering 3 product listing(s). FDA's stated reason: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| IntegraDose Compounding Services, LLC, Minneapolis, MN | Form 483 | Fentanyl | FDA issued a Form FDA 483 to IntegraDose Compounding Services, LLC, Minneapolis, MN (503B facility) on 2024-03-01. The form lists 8 observation(s), including: investigation of discrepancies and failed batches; procedures to prevent microbial contamination of sterile products; equipment design/maintenance; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| IntegraDose Compounding Services LLC | Recall | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2024-01-22; reported in the FDA Enforcement Report 2024-02-21) covering 1 product listing(s). FDA's stated reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Ranier’s Compounding Laboratory, Jeannette, PA | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Ranier’s Compounding Laboratory, Jeannette, PA (503A facility) on 2024-02-13, listing inspectional observations from an inspection dated 2/5/2024-2/13/2024. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| SSM Health Care St. Louis, (dba SSM Health St. Clare Hospital - Fenton), Fenton, MO | Form 483 | Fentanyl | FDA issued a Form FDA 483 to SSM Health Care St. Louis, (dba SSM Health St. Clare Hospital - Fenton), Fenton, MO (503B facility) on 2024-02-08. The form lists 10 observation(s), including: production and process controls; cleaning/disinfection; procedures to prevent microbial contamination of sterile products; personnel practices. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Denver Solutions, LLC DBA Leiters Health | Recall | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Le; FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Le; PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters (+3 more product listings) | Denver Solutions, LLC DBA Leiters Health initiated a recall (recall initiation 2023-12-28; reported in the FDA Enforcement Report 2024-02-07) covering 6 product listing(s). FDA's stated reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. Classification: Class I; status: Ongoing.Class I · Status: Ongoing | FDA record | |
| IntegraDose Compounding Services LLC | Recall | Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN | IntegraDose Compounding Services LLC initiated a recall (recall initiation 2024-01-12; reported in the FDA Enforcement Report 2024-01-31) covering 1 product listing(s). FDA's stated reason: Subpotent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| SNF Holdings, LLC, (dba Vios Compounding), Livonia, MI | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to SNF Holdings, LLC, (dba Vios Compounding), Livonia, MI on 2024-01-29. The letter itself is not linked on the page.Status: Listed | FDA record | |
| QuVa Pharma, Inc., Bloomsbury, NJ | Warning Letter | Oxytocin | Following an Aug-Oct 2022 inspection of QuVa Pharma (503B, Bloomsbury, NJ), FDA issued a Warning Letter citing deficiencies in sterile drug production. The letter acknowledges a 2022-09-20 voluntary recall of oxytocin 30 Units/500 mL in 0.9% sodium chloride (lot 30027403) for incorrect formulation, and reviews the firm's responses to the Form 483 issued 2022-10-14.Status: Issued | FDA record | |
| Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA on 2024-01-26. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA | Other | Not specified in source | FDA's compounding actions page lists a letter referring Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA to its state board of pharmacy, dated 2024-01-26. See the source document for content.Status: Listed | FDA record | |
| AnazaoHealth Corporation | Recall | B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/M; Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealt | AnazaoHealth Corporation initiated a recall (recall initiation 2023-11-22; reported in the FDA Enforcement Report 2024-01-03) covering 2 product listing(s). FDA's stated reason: Presence of Particulate Matter. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record |
2023 6
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | NAD+ | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503A facility) on 2023-12-01. The form lists 8 observation(s), including: ISO 5 area practices; cleaning/disinfection; environmental monitoring; component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Strive Pharmacy Texas, LLC, dba Strive Pharmacy (formerly Talon Pharmacy of Boerne) Boerne, TXOn AffinityRx | Form 483 | Semaglutide | FDA issued a Form FDA 483 to Strive Pharmacy Texas, LLC, dba Strive Pharmacy (formerly Talon Pharmacy of Boerne) Boerne, TX (503A facility) on 2023-09-08. The form lists 4 observation(s), including: facility design; personnel practices; cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Other | Not specified in source | FDA issued an Untitled Letter to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX dated 2023-06-30 following an inspection from April 12, 2022 to May 4, 2022 (Form FDA 483 issued May 4, 2022). The letter states investigators noted deficiencies in drug production practices.Status: Listed | FDA record | |
| Empower Clinic Services LLC dba Empower PharmacyOn AffinityRx | Recall | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded b | Empower Clinic Services LLC dba Empower Pharmacy initiated a recall (recall initiation 2023-05-12; reported in the FDA Enforcement Report 2023-06-14) covering 1 product listing(s). FDA's stated reason: Mislabeling: preservative free product labeled as preserved. Classification: Class II; status: Completed.Class II · Status: Completed | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2023-05-11; reported in the FDA Enforcement Report 2023-05-31) covering 1 product listing(s). FDA's stated reason: Sub-potent Drug. Classification: Class II; status: Ongoing.Class II · Status: Ongoing | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists a regulatory meeting held with Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX on 2023-05-04. No further detail is posted on the page.Status: Listed | FDA record |
2022 8
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Warning Letter | Not specified in source | Following a 2021-10-18 to 2021-11-02 inspection of Vita Pharmacy LLC dba Talon Pharmacy of Boerne (503A, Boerne, TX; later Strive Pharmacy Texas), FDA issued a Warning Letter citing sterile-processing deficiencies: airflow/design concerns, hazardous drugs handled in the same cleanroom as non-hazardous products, dirty equipment, no smoke studies and media fills not under worst-case conditions.Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Sermorelin, Ketamine, Cyanocobalamin, Pyridoxine, Estradiol | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2022-08-05, listing inspectional observations from an inspection dated 7/18/2022-8/5/2022. The form lists 17 observation(s), including: quality control unit responsibilities; procedures to prevent microbial contamination of sterile products; cleaning/disinfection; investigation of discrepancies and failed batches. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists a letter referring Promise Pharmacy, LLC, Palm Harbor, FL to its state board of pharmacy, dated 2022-07-27. See the source document for content.Status: Listed | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Promise Pharmacy, LLC, Palm Harbor, FL on 2022-07-27. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Other | Not specified in source | FDA listed a Warning Letter close-out letter for this firm on its compounding actions page.Status: Closed out | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX on 2022-05-20. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2022-05-04. The form lists 8 observation(s), including: equipment design/maintenance; cleaning/disinfection; airflow (smoke) studies. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Revive Rx LLC dba Revive Rx PharmacyOn AffinityRx | Recall | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, | Revive Rx LLC dba Revive Rx Pharmacy initiated a recall (recall initiation 2022-02-11; reported in the FDA Enforcement Report 2022-02-23) covering 1 product listing(s). FDA's stated reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus. Classification: Class I; status: Terminated.Class I · Status: Terminated | FDA record |
2021 7
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Vita Pharmacy, LLC dba Talon Compounding PharmacyOn AffinityRx | Recall | Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharm; (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE ; ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive St (+127 more product listings) | Vita Pharmacy, LLC dba Talon Compounding Pharmacy initiated a recall (recall initiation 2021-10-12; reported in the FDA Enforcement Report 2021-11-17) covering 130 product listing(s). FDA's stated reason: Lack of assurance of sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX (503A facility) on 2021-11-02. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Warning Letter | Testosterone, Pyridoxine | Following a 2020-02-12 to 2020-03-06 inspection of Empower Pharmacy's 503B outsourcing facility (Houston, TX), FDA issued a Warning Letter citing unapproved-new-drug/misbranding violations for products that did not meet 503B conditions, including pyridoxine 100 mg/mL injection compounded from a non-qualifying bulk substance. It also cites failure to submit complete product reports to FDA (Dec 2019, June 2020).Status: Issued | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TXOn AffinityRx | Form 483 | Not specified in source | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Compounding Pharmacy), San Antonio, TX (503A facility) on 2021-10-06. The form lists 3 observation(s), including: cleaning/disinfection. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Form 483 | Bpc-157, Ipamorelin | FDA issued a Form FDA 483 to Promise Pharmacy, LLC, Palm Harbor, FL (503A facility) on 2021-09-23. The form lists 1 observation(s), including: component testing/handling. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Promise Pharmacy, LLCOn AffinityRx | Recall | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial ste | Promise Pharmacy, LLC initiated a recall (recall initiation 2021-06-30; reported in the FDA Enforcement Report 2021-09-22) covering 1 product listing(s). FDA's stated reason: Lack of processing controls. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record | |
| Revive RX LLC, dba Revive RX Pharmacy, Houston, TXOn AffinityRx | Form 483 | Ipamorelin | FDA issued a Form FDA 483 to Revive RX LLC, dba Revive RX Pharmacy, Houston, TX (503A facility) on 2021-08-06. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record |
2020 3
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX on 2020-07-08. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Form 483 | Glutathione, Testosterone, Pyridoxine | FDA issued a Form FDA 483 to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX (503B facility) on 2020-03-06. The form lists 6 observation(s), including: quality control unit responsibilities; labeling required of outsourcing facilities; adverse event reporting. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record | |
| Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TXOn AffinityRx | Form 483 | Estradiol | FDA issued a Form FDA 483 to Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX (503A facility) on 2020-02-11. The form lists inspectional observations; topics could not be reliably extracted from the scanned PDF. Form FDA 483 observations are inspectional and do not represent a final FDA determination of compliance.Status: Issued (inspectional observations) | FDA record |
2019 4
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Promise Pharmacy, LLC, Palm Harbor, FLOn AffinityRx | Warning Letter | Bremelanotide | FDA inspected Promise Pharmacy (503A, Palm Harbor, FL) in 2018 and issued a Form 483 on 2018-10-25 (amended 2018-11-12). The letter cites insanitary sterile-compounding conditions (particulates in a prednisolone/gatifloxacin ophthalmic lot, an inadequate non-hazardous cleanroom, poor aseptic practice) and a released bremelanotide 20 mg injectable that assayed at 114.3% of label strength. It acknowledges recalls on 2018-10-22 and 2018-12-13 and a voluntary pause of sterile operations.Status: Issued | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Sermorelin, Pyridoxine | FDA issued an Untitled Letter to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX dated 2019-07-22 following an inspection from January 10, 2018 to January 24, 2018 (Form FDA 483 issued January 24, 2018). The letter states investigators noted drug products failed to meet conditions of section 503B for exemption.Status: Listed | FDA record | |
| Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TXOn AffinityRx | Other | Not specified in source | FDA's compounding actions page lists an FMD-145 letter issued to Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX on 2019-04-02. The letter itself is not linked on the page.Status: Listed | FDA record | |
| Promise Pharmacy, LLCOn AffinityRx | Recall | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US ; Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription,; Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, (+48 more product listings) | Promise Pharmacy, LLC initiated a recall (recall initiation 2018-12-17; reported in the FDA Enforcement Report 2019-02-20) covering 51 product listing(s). FDA's stated reason: Lack of sterility assurance. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record |
2018 1
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Promise Pharmacy LLCOn AffinityRx | Recall | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Pa | Promise Pharmacy LLC initiated a recall (recall initiation 2018-10-18; reported in the FDA Enforcement Report 2018-10-31) covering 1 product listing(s). FDA's stated reason: Presence of precipitate. Classification: Class III; status: Terminated.Class III · Status: Terminated | FDA record |
2016 1
| Date | Firm | Type | Products | Summary | Source |
|---|---|---|---|---|---|
| Talon Compounding PharmacyOn AffinityRx | Recall | Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 i; Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by | Talon Compounding Pharmacy initiated a recall (recall initiation 2016-07-19; reported in the FDA Enforcement Report 2016-08-31) covering 2 product listing(s). FDA's stated reason: Lack of Assurance of Sterility. Classification: Class II; status: Terminated.Class II · Status: Terminated | FDA record |
No actions match that filter.
How AffinityRx handles FDA actions for clinics
AffinityRx tracks FDA actions so clinics don't have to, as one part of vetting every compounding pharmacy on the platform.
- Vetting: AffinityRx reviews pharmacies in five areas (compliance, product, track record, market feedback and operations); track record covers Form 483s, recalls, FDA actions and the pharmacist-in-charge background. Only 9% of the pharmacies AffinityRx reviews pass.
- Notification: if a pharmacy on AffinityRx receives an FDA warning letter or recall, AffinityRx notifies clinics and adds it to the pharmacy profile.
- Control: clinics can switch that pharmacy off in their portal, and orders fail over to the next favorite pharmacy within 1–2 minutes.
See the pharmacy directory for each profile, how failover works and how AffinityRx compares with other compounding pharmacy marketplaces.
Methodology and scope
AffinityRx compiles this index from FDA sources and last checked it on Oct 1, 2026.
- Scope: FDA actions involving human-drug compounders (503A pharmacies and 503B outsourcing facilities) from January 1, 2024 through Oct 1, 2026, plus any older action involving a pharmacy on AffinityRx.
- Types: warning letters, recalls, Form 483 inspection observations, import alerts and other actions. Each row shows the date, firm, type, products, a short factual summary and a link to the FDA source.
- Pharmacies on AffinityRx are marked and linked to their profiles. A listing is a dated record, not a conclusion about any firm's current compliance, and AffinityRx updates a pharmacy's profile and notifies clinics when an action involves a pharmacy on the platform.
- Records can be incomplete or change. Verify against FDA and the relevant state board before relying on a record.
Frequently asked questions about FDA actions against compounding pharmacies
How many FDA warning letters have compounding pharmacies received since 2024?
AffinityRx's FDA actions index lists 30 warning letters to human-drug compounding pharmacies and outsourcing facilities from Aug 31, 2016 through Oct 1, 2026. The index also lists 85 recalls, 116 Form 483s, and 75 other actions.
What is the difference between an FDA warning letter, a recall and a Form 483?
A Form 483 lists observations an FDA investigator made at the end of an inspection. A warning letter is a formal FDA notice that a firm appears to violate the law and must correct the violations. A recall is an action to remove a product from the market, usually carried out by the firm and classified by FDA. Each is a different record, and none alone describes a pharmacy's overall compliance.
What does AffinityRx do when a pharmacy gets an FDA warning letter or recall?
AffinityRx notifies clinics, adds the action to the pharmacy's profile, and clinics can switch that pharmacy off in their AffinityRx portal. AffinityRx also tracks Form 483s and FDA actions as part of vetting every pharmacy, and only 9% of the pharmacies it reviews pass.
Does an FDA action mean a compounding pharmacy is unsafe?
Not by itself. An FDA action is a dated record of an agency finding or event. AffinityRx weighs it in vetting, and clinics can read the summary and the FDA source, check whether the issue was closed, and review the pharmacy's licenses, accreditations and regulatory history on its AffinityRx profile.
How does AffinityRx compile this FDA actions index?
AffinityRx compiles FDA warning letters, recalls, Form 483s and related actions for human-drug compounders (503A pharmacies and 503B outsourcing facilities) from FDA sources, from January 1, 2024 through Oct 1, 2026, plus any older action involving a pharmacy on AffinityRx. Each row links to its FDA source. The index was last checked Oct 1, 2026.
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AffinityRx vets every pharmacy, and pharmacy profiles show licenses, accreditations and regulatory history side by side.
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