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.
Product description
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 numbers, UPCs & expiration codes
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.
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0286-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 27, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- 258,750 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-0286-2025, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96325
- Address
- 1 Amgen Center Dr
- Code information
- 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.
- Postal code
- 91320-1730
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0286-2025
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Product quantity
- 258,750 Vials
- Reason for 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- 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.
- Recall initiation date
- Feb 27, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2025