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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
Mar 17, 2025 Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... Failed dissolution specifications: lower than specifications Class II BIOCON PHARMA INC
Jan 31, 2023 Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manuf... Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. Class II BIOCON PHARMA INC
Jan 28, 2020 Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufact... Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tabl... Class II Graviti Pharmaceuticals Private Limited

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.