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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)

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.