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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
Jan 12, 2018 Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30... Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... Class II International Laboratories, Inc.
Jan 12, 2018 Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30... Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... Class II International Laboratories, Inc.
Aug 7, 2017 Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged fo... Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with B... Class I International Laboratories, 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.