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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2018 Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:... Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-min... Class III Hetero Labs, Ltd. - Unit III
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... Class II Hetero Labs, Ltd. - Unit III
Jan 10, 2018 Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II Hetero Labs, Ltd. - Unit III
Dec 22, 2017 Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... Presence of foreign substance: metallic razor blade was found in one bottle. Class III Hetero Labs, Ltd. - Unit III
Oct 12, 2017 Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) ... Presence of foreign substance (screw) Class II Hetero Labs, Ltd. - Unit III

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.