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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Aug 23, 2013 NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMAC... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS ... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELL... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 The product lots are being recalled due to laboratory results indicating microbial contamination.... Class II Wellness Pharmacy, Inc.
Aug 23, 2013 Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-2... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results ind... Class II Wellness Pharmacy, 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.