Amgen Recalls Multiple Lots of Neupogen Due to Potential Stability Concerns

Amgen Inc. has initiated a voluntary Class II recall of several lots of Neupogen (filgrastim) for injection, including both the 300 mcg/1 mL and 480 mcg/1.6 mL (300 mcg/mL) formulations. The recall affects a total of 572 370 vials distributed nationwide in the US and internationally across more than 25 countries. The action was taken after stability data indicated the potential for the product to fall out of specification by its labeled 36-month expiry date.

The recall encompasses numerous lot numbers with expiration dates ranging from February 2025 through July 2027, all supplied in preservative-free, single-dose vials for subcutaneous or intravenous administration. Although no adverse events have been reported, Amgen notified consignees via letter beginning February 27, 2025. The US Food and Drug Administration (FDA) officially classified the recall on March 18, 2025. Affected product bears NDC numbers 55513-530-01/10 and 55513-546-01/10, and no press release has been issued to date.

Filgrastim is an FDA-approved recombinant human granulocyte colony-stimulating factor (G-CSF) used to reduce the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy, among other indications. It stimulates the production of neutrophils, a critical defense against infection, and is also used in bone marrow transplantation and for patients undergoing peripheral blood progenitor cell collection. Pharmacists should review their inventory and quarantine affected lots to ensure product integrity.