US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Feb 27, 2025 (2 years ago)

Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

What was recalled

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).

Recalling firm
Amgen, Inc.
NDC code
55513-530-01
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0285-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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