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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
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.
Jul 7, 2015 Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24... Class II Kremers Urban Pharmaceuticals, Inc.
Jul 7, 2015 Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only... Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity ... Class II Kremers Urban Pharmaceuticals, Inc.
Sep 16, 2013 Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per b... Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not ... Class II Kremers Urban Pharmaceuticals, 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.