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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Oct 28, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... Class II Teva Pharmaceuticals USA
Aug 30, 2016 Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... Class III Actavis Laboratories, FL, Inc.
Sep 25, 2015 Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. Class II Actavis Laboratories, FL, Inc.
Jun 23, 2015 Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III Actavis Laboratories, FL, Inc.
Mar 26, 2015 Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... Class III Actavis Laboratories, FL, Inc.
Sep 26, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Presence of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, 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.