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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Oct 9, 2025 Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bo... Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity... Class II USV Private Limited
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-5... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-58... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage Pharmaceuticals Inc
Oct 6, 2025 Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-57... CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake... Class II Heritage 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.