Amgen, Inc. recalls Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous o
Recalled March 26, 2025 · FDA recall D-0286-2025 · Amgen
Hazard
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. · FDA Class II
Units
258,750 Vials
Sold at
Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.
Description
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Product
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
Manufacturer(s)
Amgen, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →