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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
Jan 18, 2019 Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Prinston Pharmaceutical Inc
Jan 18, 2019 Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Onl... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Prinston Pharmaceutical Inc
Jan 18, 2019 Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Prinston Pharmaceutical Inc
Jan 18, 2019 Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huah... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Prinston Pharmaceutical Inc
Jan 18, 2019 Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Jul 13, 2018 Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Prinston Pharmaceutical Inc
Nov 29, 2017 Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Z... Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets... Class II Prinston Pharmaceutical Inc
May 30, 2016 Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufa... Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on ... Class III Prinston Pharmaceutical 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.