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.

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DateProductReasonClassFirm
Feb 24, 2026 Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... Failed Dissolution Specifications Class II MYLAN PHARMACEUTICALS INC
Feb 13, 2026 Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification ... Class II AvKARE
Jan 29, 2026 Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets b... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Jan 29, 2026 Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, R... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Jan 29, 2026 Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (ND... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Jan 29, 2026 Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (ND... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II AvKARE
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2025 NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Oct 10, 2025 Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... Failed Dissolution Specifications Class II Lannett Company Inc.
Sep 29, 2025 Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... Failed dissolution specifications: Stability testing found that the lot did not meet dissolution ... Class II Acella Pharmaceuticals, LLC
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-51... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 6787... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Sep 19, 2025 Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-... Failed Dissolution Specifications Class II Ascend Laboratories, 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
Sep 3, 2025 Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufacture... Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium T... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Aug 8, 2025 Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manuf... Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by ... Class II Glenmark Pharmaceuticals Inc., USA
Jul 21, 2025 Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton... Failed Dissolution Specifications: potential for delayed dissolution of the dose after administra... Class II Merck & Co. Inc
Jul 21, 2025 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx... Failed Dissolution Specifications: low dissolution results Class II Ascend Laboratories, LLC
Jul 9, 2025 Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... Failed Dissolution Specifications. Class II Strides Pharma, Inc.
Jun 24, 2025 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... Class II Granules Pharmaceuticals Inc.
Jun 16, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 15, 2025 Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bo... OOS results reported for the Dissolution (by UV) test. Class II Glenmark Pharmaceuticals Inc., USA
May 9, 2025 Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per car... Failed Dissolution Specifications Class II AvKARE
Mar 17, 2025 Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... Failed dissolution specifications: lower than specifications Class II BIOCON PHARMA INC
Mar 5, 2025 PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Mar 4, 2025 Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... Failed Dissolution Specifications: Out of specification results obtained during routine stability... Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Feb 25, 2025 Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Myl... Failed Dissolution Specifications - low dissolution results Class II MYLAN PHARMACEUTICALS INC
Feb 6, 2025 Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 30, 2025 Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablet... Failed Dissolution Specifications. Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Man... Out of Specification for Dissolution Class II AvKARE
Dec 18, 2024 Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... Failed Dissolution Specifications: Out of specification observed during the accelerated stability... Class II Granules Pharmaceuticals Inc.
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 4, 2024 Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... Failed Dissolution Specifications Class II AvKARE
Sep 3, 2024 Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets p... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Jul 31, 2024 Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count b... Failed Dissolution Specifications: below specification results Class II Glenmark Pharmaceuticals Inc., USA
Jul 9, 2024 Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules p... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 28, 2024 Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 684... Failed Dissolution Specifications: results below specifications Class II Glenmark Pharmaceuticals Inc., USA
Jun 26, 2024 Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... CGMP Deviations: Out of specification for dissolution Class II RemedyRepack Inc.
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
Jun 21, 2024 Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in ... Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing ... Class II Zydus Pharmaceuticals (USA) Inc
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...

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.