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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jul 29, 2019 Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... Failed Dissolution Specifications Class II Upsher Smith Laboratories, Inc.
Sep 19, 2018 Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: U... Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... Class II Upsher Smith Laboratories, Inc.
Sep 19, 2018 Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: U... Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified... Class II Upsher Smith Laboratories, Inc.
Apr 14, 2014 Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufacture... Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the p... Class III Upsher Smith Laboratories, Inc.
Dec 10, 2012 Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity... Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded ... Class III Upsher Smith Laboratories, Inc.
Nov 20, 2012 Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules... Failed Dissolution Test Requirements Class II Upsher Smith 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.