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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
Dec 16, 2025 Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, M... Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... Class III Alembic Pharmaceuticals Limited
Oct 10, 2025 Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx on... Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... Class III Alembic Pharmaceuticals Limited
Jul 25, 2025 Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... Class II Alembic Pharmaceuticals Limited
May 9, 2025 Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alemb... Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a ... Class II Alembic Pharmaceuticals Limited
May 7, 2025 Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufac... Failed Impurities/Degradation Specifications Class II Alembic Pharmaceuticals Limited
Jun 22, 2023 Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles... Defective Delivery System Class II ALEMBIC PHARMACEUTICALS, INC.
Mar 17, 2021 Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A... Labeling: Label-mixup Class I Alembic Pharmaceuticals Limited
Jun 10, 2020 Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured... Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tabl... Class II Alembic Pharmaceuticals Limited

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.