FDA Drugs recall ·
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials… recall
- Recall number
- D-0285-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- Amgen, Inc.
1 Amgen Center Dr, Thousand Oaks, CA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 313,620 Vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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).
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0285-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.