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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Jul 12, 2014 Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bot... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 m... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 3... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg,... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufac... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development

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.