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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Jan 21, 2026 Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed b... Tablets/Capsules Imprinted with Wrong ID Class III Unichem Pharmaceuticals USA Inc.
Jan 21, 2026 Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100... cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. Class II Unichem Pharmaceuticals USA Inc.
Aug 27, 2025 Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, ... Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were... Class I Unichem Pharmaceuticals USA Inc.
Sep 19, 2022 Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manu... Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 ... Class III UNICHEM PHARMACEUTICALS USA INC
Oct 25, 2021 Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... Discoloration Class III UNICHEM PHARMACEUTICALS USA INC
May 26, 2020 Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low lev... Class III UNICHEM PHARMACEUTICALS USA INC
Jan 29, 2020 Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure... Class III UNICHEM PHARMACEUTICALS USA INC
Dec 19, 2017 Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalpro... Class II Unichem Pharmaceuticals Usa Inc
Oct 2, 2017 Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o... Class II Unichem Pharmaceuticals Usa Inc
Aug 19, 2016 Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Man... Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. Class III Unichem Pharmaceuticals Usa Inc
Jul 30, 2015 Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactur... Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of ... Class II Unichem Pharmaceuticals Usa 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.