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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Neupogen (filgrastim) Recalled for Potential Loss of Potency Before Expiry

Agency Publication Date: March 18, 2025
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Summary

Amgen, Inc. is recalling 572,370 vials of Neupogen (filgrastim) For Injection because stability testing indicates the medication may not maintain its required specifications through its 36-month expiration date. This recall involves 300 mcg/1 mL and 480 mcg/1.6 mL single-dose vials that were distributed across the United States and multiple international countries. If you use this medication, you should consult your doctor or pharmacist to determine if your specific supply is affected and to discuss your ongoing treatment plan.

Risk

The drug may lose potency or fall out of required quality standards sooner than the expiration date printed on the package. This could mean the medication is less effective than intended by the time it is administered to a patient.

What You Should Do

  1. This recall affects Neupogen (filgrastim) For Injection, 300 mcg/1 mL and 480 mcg/1.6 mL single-dose vials sold under the Amgen Inc. brand.
  2. To identify affected products, check the package for NDC codes 55513-530-01, 55513-530-10, 55513-546-01, or 55513-546-10. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Neupogen (filgrastim) For Injection (300mcg/1 mL)
Variants: 300mcg/1 mL, 1 mL Single Dose Vials, Sterile Solution
Lot Numbers:
1147300 (Exp. 2/28/2025)
1147300A (Exp. 2/28/2025)
1152064 (Exp. 3/31/2025)
1154734 (Exp. 8/31/2025)
1156806 (Exp. 8/31/2025)
1159109 (Exp. 10/31/2025)
1163909 (Exp. 2/28/2026)
1164631 (Exp. 5/31/2026)
1171366 (Exp. 8/31/2026)
1182097 (Exp. 8/31/2026)
1176114 (Exp. 2/28/2027)
1182094 (Exp. 7/31/2027)
NDC:
55513-530-01
55513-530-10

Quantity: 313,620 Vials. Recall #: D-0285-2025.

Product: Neupogen (filgrastim) For Injection (480 mcg/1.6 mL)
Variants: 480 mcg/1.6 mL, 1.6 mL single Dose Vial, Sterile Solution
Lot Numbers:
1147308 (Exp. 2/28/2025)
1154183 (Exp. 2/28/2025)
1156807 (Exp. 6/30/2025)
1160222 (Exp. 6/30/2025)
1160223 (Exp. 2/28/2026)
1163912 (Exp. 2/28/2026)
1167352 (Exp. 2/28/2026)
1171365 (Exp. 11/30/2026)
1175057 (Exp. 11/30/2026)
1176250 (Exp. 11/30/2026)
NDC:
55513-546-01
55513-546-10

Quantity: 258,750 Vials. Recall #: D-0286-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96325
Status: Active
Manufacturer: Amgen, Inc.
Sold By: Hospitals; Pharmacies; Wholesalers; Infusion centers; Specialty retailers
Manufactured In: United States
Units Affected: 2 products (313,620 Vials; 258,750 Vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.