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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
Sep 10, 2021 Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufac... Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the... Class II Piramal Critical Care, Inc.
Jul 8, 2019 Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packag... Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due t... Class II Piramal Critical Care, Inc.
Apr 7, 2014 Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manuf... Failed pH Specifications: product was too acidic. Class II Piramal Critical Care, 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.