Neupogen 300mcg (Amgen) – Stability Expiration Issue (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).
Brand
Amgen, Inc.
Lot Codes / Batch Numbers
Lot #: 1147300, 1147300A, Exp.: 2/28/2025, 1152064, Exp.:3/31/2025, 1154734, 1156806, Exp.: 8/31/2025, 1159109, Exp.: 10/31/2025, 1163909, Exp.: 2/28/2026, 1164631, Exp.: 5/31/2026, 1171366, 1182097, Exp.:8/31/2026, 1176114, Exp.: 2/28/2027, 1182094, Exp.:7/31/2027.
Products Sold
Lot #: 1147300, 1147300A, Exp.: 2/28/2025; 1152064, Exp.:3/31/2025; 1154734, 1156806, Exp.: 8/31/2025; 1159109, Exp.: 10/31/2025; 1163909, Exp.: 2/28/2026; 1164631, Exp.: 5/31/2026; 1171366, 1182097, Exp.:8/31/2026; 1176114, Exp.: 2/28/2027; 1182094, Exp.:7/31/2027.
Amgen, Inc. is recalling Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous due to Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026