Neupogen (filgrastim) For Injection recall
FDA recall D-0286-2025 · initiated Feb 27, 2025
Amgen, Inc. recalled Neupogen (filgrastim) For Injection in Feb 2025 — an FDA Class II recall (D-0286-2025) because Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 258,750 Vials
Details
- 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).
- Recalling company
- Amgen Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- 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.
- Initiated
- Feb 27, 2025
- FDA report date
- Mar 26, 2025
This recall is linked to a product we cover: Neupogen →
Frequently asked
- Was Neupogen (filgrastim) For Injection recalled?
- Amgen, Inc. recalled Neupogen (filgrastim) For Injection in Feb 2025 — an FDA Class II recall (D-0286-2025) because Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Neupogen (filgrastim) For Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0286-2025 was: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
- Is a recalled Neupogen (filgrastim) For Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Neupogen (filgrastim) For Injection are affected?
- Distributed: 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.. The recall covers these lots — Lot 1147308, 1154183, Exp.: 2/28/2025; 1156807, 1160222, Exp.: 6/30/2025; 1160223, 1163912, 1167352, Exp.: 2/28/2026; 1171365, 1175057, 1176250, Exp.: 11/30/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0286-2025.