Browse Drug Recalls
43 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 43 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 43 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 14, 2026 | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) bliste... | Defective container: Multiple customer complaints received for card seal defects observed on the ... | Class II | Amerisource Health Services LLC |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services LLC |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services LLC |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services LLC |
| Oct 9, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it c... | Class II | Amerisource Health Services LLC |
| Sep 15, 2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x... | Failed Dissolution Specifications. | Class II | Amerisource Health Services LLC |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) bl... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amerisource Health Services LLC |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack pe... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amerisource Health Services LLC |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, R... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amerisource Health Services LLC |
| Aug 27, 2025 | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack pe... | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packa... | Class II | Amerisource Health Services LLC |
| Jul 29, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Amerisource Health Services LLC |
| May 15, 2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... | cGMP deviations | Class II | Amerisource Health Services LLC |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, M... | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Class II | Amerisource Health Services LLC |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx On... | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Class II | Amerisource Health Services LLC |
| Apr 2, 2025 | Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx o... | Lack of assurance of sterility. Bacterial contamination detected in some media fill units | Class II | Amerisource Health Services LLC |
| Mar 24, 2025 | Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 i... | cGMP Deviations: Received notification from their supplier requesting they perform a recall due t... | Class II | Amerisource Health Services LLC |
| Jan 7, 2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II | Amerisource Health Services LLC |
| Dec 17, 2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... | Failed Dissolution Specifications: | Class II | Amerisource Health Services LLC |
| Dec 13, 2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II | Amerisource Health Services LLC |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Class II | Amerisource Health Services LLC |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Ma... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Class II | Amerisource Health Services LLC |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Ma... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Class II | Amerisource Health Services LLC |
| Dec 6, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Jun 25, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... | Failed Dissolution Specifications | Class I | Amerisource Health Services LLC |
| Jun 24, 2024 | buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg,... | Failed Dissolution Specifications; the product is dissolving faster than the specified limits. | Class II | Amerisource Health Services LLC |
| Feb 1, 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... | Class III | Amerisource Health Services LLC |
| Jan 25, 2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... | CGMP Deviations | Class II | Amerisource Health Services LLC |
| Jan 11, 2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx... | Failed Impurities/Degradation Specification. | Class II | Amerisource Health Services LLC |
| Dec 26, 2023 | Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose c... | Superpotent drug: Assay results were slightly above specification at the time zero point. | Class III | Amerisource Health Services LLC |
| Sep 1, 2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod... | Class III | Amerisource Health Services LLC |
| Jun 23, 2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... | Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... | Class II | Amerisource Health Services LLC |
| Mar 17, 2023 | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 6800... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Amerisource Health Services LLC |
| Mar 17, 2023 | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 6... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Amerisource Health Services LLC |
| Mar 17, 2023 | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 680... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Amerisource Health Services LLC |
| Mar 16, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... | Failed Dissolution Specifications: Out of specification dissolution results above specified values. | Class II | Amerisource Health Services LLC |
| Jan 27, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... | Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... | Class II | Amerisource Health Services LLC |
| Jan 11, 2023 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... | Failed Dissolution Specifications: This recall is being initiated in support of the recall by the... | Class II | Amerisource Health Services LLC |
| Dec 27, 2022 | BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton,... | Failed Impurities/Degradation Specifications | Class II | Amerisource Health Services LLC |
| Dec 20, 2022 | Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... | Failed Impurities/Degradations Specifications | Class II | Amerisource Health Services LLC |
| Jul 27, 2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... | Subpotent Drug | Class III | Amerisource Health Services LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.