Browse Drug Recalls
392 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 392 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 392 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2024 | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count... | Failed dissolution specifications: this product is being recalled due to this batch not meeting d... | Class II | Trigen Laboratories |
| Jun 12, 2024 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... | Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing... | Class II | PACIRA PHARMACEUTICALS INC |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| Apr 17, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 27, 2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... | Class III | Esperion |
| Mar 26, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 7, 2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Feb 20, 2024 | Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... | Failed Dissolution Specifications | Class II | Eugia US LLC |
| Feb 9, 2024 | Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... | Failed Dissolution Specifications: results slightly under spec at at 9-months. | Class III | Stason Pharmaceuticals, Inc. |
| Feb 5, 2024 | Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 12, 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Markete... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Dec 29, 2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: St... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| 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 |
| Nov 22, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 22, 2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... | Failed Dissolution Specifications | Class II | Lupin Pharmaceuticals Inc. |
| Nov 20, 2023 | Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured ... | Failed Dissolution Specifications | Class III | Siegfried Barbera, SL |
| 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 |
| Oct 23, 2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx ... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 4, 2023 | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 21, 2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 16, 2023 | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Man... | Failed dissolution specifications: below specification results at stability 12-month | Class III | Esperion |
| Aug 2, 2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... | Failed dissolution specifications - results obtained were below spec average. | Class II | Aurobindo Pharma USA Inc. |
| Jul 11, 2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... | Failed Dissolution Specifications | Class II | Ascend Laboratories, 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 |
| Jun 21, 2023 | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... | Failed dissolution specification: Out of specification results observed in 24-month long term sta... | Class II | Dr Reddy's Laboratories Limited |
| 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 9, 2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... | Failed Dissolution Specifications; during stability testing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 13, 2023 | Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... | Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 5, 2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... | Failed Dissolution Specification | Class II | Ascend Laboratories, LLC |
| Jan 4, 2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... | Class III | Intersect ENT, Inc. |
| Nov 21, 2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 18, 2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 18, 2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
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.