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.

Clear
DateProductReasonClassFirm
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.