Browse Drug Recalls

17 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17 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 17 FDA drug recalls.

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DateProductReasonClassFirm
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Nov 3, 2021 Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alke... Failed Impurities/Degradation Specifications Class II Ascend Laboratories LLC
Apr 29, 2021 Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured b... Presence of Foreign Tablet/Capsule Class III Ascend Laboratories LLC
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Dec 17, 2020 Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... Failed Impurity/Degradation Specifications Class II Ascend Laboratories LLC
Dec 17, 2020 Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... Failed Impurity/Degradation Specifications Class II Ascend Laboratories LLC
Nov 24, 2020 Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by... Failed Dissolution Specifications; Out of Specification (low) results were obtained. Class II Ascend Laboratories LLC
Nov 23, 2020 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (... Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specificat... Class II Ascend Laboratories LLC
Jan 24, 2020 Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... Class II Ascend Laboratories LLC
Jan 22, 2020 Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... Failed Dissolution Specifications: low out of specification results for dissolution testing. Class III Ascend Laboratories LLC
Jul 19, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... Failed Dissolution Specifications Class II Ascend Laboratories LLC
Feb 22, 2019 Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... Class II Ascend Laboratories LLC
Nov 14, 2018 Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:... Presence of Foreign Substance; metal shard found in tablet Class II Ascend Laboratories LLC
May 5, 2017 AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... Class III Ascend Laboratories LLC
Nov 2, 2016 Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu... Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of... Class II Ascend Laboratories 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.