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
May 28, 2026 Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Aja... CGMP Deviations Class II Ajanta Pharma USA Inc
May 27, 2026 Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pha... Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as A... Class II Ajanta Pharma USA Inc
May 14, 2026 Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Asclemed USA Inc.
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 2724... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.

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.