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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
May 18, 2021 PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989

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.