Lower risk Drug recall · FDA · Published February 27, 2025

Amgen Neupogen Injection Recall: Stability Issues Before Expiry

Amgen recalls Neupogen (filgrastim) vials that may lose potency before their 36-month expiry date. This could affect medication effectiveness if used after the stability period ends.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0285-2025Drug Amgen ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmAmgen, Inc.1 Amgen Center Dr · Thousand Oaks, CA 91320-1730

✎ GovInfoNow plain-language explainer

Amgen is recalling Neupogen (filgrastim) injection vials that may become unstable before their 36-month expiration date. Using these vials after the stability period ends could lead to reduced medication effectiveness. Read more at govinfonow.com/recall/32262-amgen-neupogen-injection-recall-stability-issues-before-expiry.

Source Summary by GovInfoNow · govinfonow.com/recall/32262-amgen-neupogen-injection-recall-stability-issues-before-expiry · Updated August 17, 2026 · FDA enforcement record: FDA #D-0285-2025

Cite this page

“Amgen Neupogen Injection Recall: Stability Issues Before Expiry.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32262-amgen-neupogen-injection-recall-stability-issues-before-expiry. Based on FDA recall #D-0285-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0285-2025%22&limit=1).

The FDA announced on Feb. 27, 2025, that Amgen, Inc. is voluntarily recalling Neupogen (filgrastim) For Injection due to stability data not supporting the expiry date. The products have the potential to be out of specification at the time of expiry of 36-months.

How to tell if you have it

Brand: Amgen
Product: Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials
NDC 55513-530-01 (vial), NDC 55513-530-10 (box)
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
Quantity: 313,620 Vials

The 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.

Context

GovInfoNow's records show Amgen, Inc. has 6 other recalls on record since 2013-09-17. Other recent recalls of similar products include Amgen Sensipar 90mg tablets (2026-06-04), Amgen MVASI injection (2022-05-02), and Amgen Procrit 10,000 units/mL (2017-09-13). Other recent recalls of similar products include Safecor Health Fluphenazine Elixir Recall (2026-08-13), Somerset Therapeutics Dexamethasone Injection Recall (2026-02-04), and Cipla Phytonadione Injectable Emulsion Recall (2025-10-31).

How to tell if you have this one

Check for vial lot numbers: 1147300, 1147300A (expiring 2/28/2025), 1152064 (expiring 3/31/2025), and other listed lots with specific expiration dates.

Brand
Amgen
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.
NDC
55513-530-01, 55513-530-10, 55513-530-20, 55513-546-01, 55513-546-10, 55513-546-20, 55513-924-01, 55513-924-10, 55513-924-91, 55513-924-20, 55513-209-01, 55513-209-10, 55513-209-91, 55513-209-20

Recall number	Product, codes & lots	Quantity
D-0285-2025	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).; 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.	313,620 Vials
D-0286-2025	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).; 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.	258,750 Vials

Based on the official FDA remedy

What to do — step by step

Check Vial Expiry
Verify the vial's expiration date against the listed dates (e.g., 2/28/2025, 3/31/2025, etc.) to ensure it hasn't expired.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 27 days after the firm started it.

Feb 27, 2025Firm started the recall
Mar 18, 2025FDA classified it Class II
Mar 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if I have a recalled vial?

Check the vial lot number against the listed numbers: 1147300, 1147300A, 1152064, 1154734, 1156806, 1159109, 1163909, 1164631, 1171366, 1182097, 1176114, 1182094.

Similar recalls

Other Amgen recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32262-amgen-neupogen-injection-recall-stability-issues-before-expiry">Amgen Neupogen Injection Recall: Stability Issues Before Expiry (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0285-2025 (February 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0285-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.