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Browse Drug Recalls

10 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 10 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 10 FDA drug recalls.

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DateProductReasonClassFirm
Aug 20, 2018 Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tabl... Class II Hetero Labs Limited Unit V
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... Class I Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Feb 13, 2018 Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... Class II Hetero Labs Limited Unit V
Feb 13, 2018 Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for C... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... Class II Hetero Labs Limited Unit V
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 Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Cam... Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled ... Class II Hetero Labs Limited Unit V

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.