Browse Drug Recalls
26 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 26 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 26 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Mar 21, 2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... | Superpotent Drug: Due to overfilling of drug powder | Class I | Amneal Pharmaceuticals of New York, LLC |
| Feb 13, 2024 | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... | Failed Impurities/Degradation Specifications: Out-of-specification test results. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jan 15, 2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,... | Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Dec 26, 2023 | Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,... | Failed dissolution specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| Oct 27, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... | Failed Dissolution Specifications | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 30, 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... | Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 8, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... | Class III | Amneal Pharmaceuticals of New York, LLC |
| Jul 27, 2022 | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... | Failed dissolution specifications. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Nov 4, 2021 | Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bot... | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Nov 4, 2021 | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bott... | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only,... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 coun... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| Apr 15, 2020 | Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... | CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... | Class II | Amneal Pharmaceuticals of New York, LLC |
| Aug 3, 2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... | Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. | Class I | Amneal Pharmaceuticals of New York, LLC |
| Aug 17, 2013 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne... | Failed dissolution specifications; 18 month CRT | Class II | Amneal Pharmaceuticals of New York, 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.