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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Feb 27, 2025 Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
Feb 27, 2025 Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... Stability data does not support expiry: the products have the potential to be out of specificatio... Class II Amgen, Inc.
May 2, 2022 MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution,... Defective container: loose crimp defect, potential loss of container integrity. Class II Amgen, Inc.
Sep 13, 2017 Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1... Presence of particulate matter: glass flakes identified as lamellae observed during a routine qua... Class II Amgen, Inc.
Aug 4, 2017 Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... Class II Amgen, Inc.
Dec 15, 2016 AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p... Lack of Assurance of Sterility: Potential cracks in glass vials Class II Amgen, Inc.
Sep 17, 2013 Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syring... Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefi... Class II Amgen, 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.