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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
Apr 18, 2017 BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 co... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg val... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, suppl... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count pa... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplie... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Apr 18, 2017 ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... Class I Organic Herbal Supply
Feb 16, 2017 XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg ... Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tada... Class I Organic Herbal Supply

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.