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Browse Drug Recalls

54 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 54 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 54 FDA drug recalls.

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DateProductReasonClassFirm
May 28, 2015 Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: U... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only.... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamin... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, Inc.
May 28, 2015 Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx On... Lack of Assurance of Sterility: Sterility of product is not assured. Class II Lincare, 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.