Browse Drug Recalls

30 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 30 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 30 FDA drug recalls.

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DateProductReasonClassFirm
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Mar 7, 2025 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... Super-Potent Drug: Out of specification potency results were obtained. Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 18, 2019 Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Aug 14, 2018 Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c... Failed Impurities/Degradation Specifications; out of specification results for related compound p... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 21, 2017 Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 27, 2017 Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 28, 2016 Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 28, 2016 Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10... Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 28, 2016 Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Nov 2, 2015 Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 26, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 28, 2014 Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... Failed Impurity/degradation Specification Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 26, 2013 LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 26, 2013 CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Dec 14, 2012 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tabl... Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both... Class I Mylan Institutional, Inc. (d.b.a. UDL Laborator...

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.