Neupogen — Class II drug recall D-0285-2025
Ongoing recall by Amgen, Inc., reported 2025-03-26, distributed nationwide. Stability data does not support expiry: the products have the potential to be out of specification at the time
| Recall number | D-0285-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amgen, Inc., Thousand Oaks, CA, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CH, CL, CO, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, LU, MY, NL, PH, PL, SA, SE |
| Quantity | 313,620 vials |
| Reason classes | specification failure |
| NDC | 55513-0209, 55513-0209-01, 55513-0209-10, 55513-0209-20, 55513-0209-91, 55513-0530, 55513-0530-01, 55513-0530-10, 55513-0530-20, 55513-0546, 55513-0546-01, 55513-0546-10, 55513-0546-20, 55513-0924, 55513-0924-01, 55513-0924-10, 55513-0924-20, 55513-0924-91 |
| Lot numbers | 1147300, 1147300A, 1152064, 1154734, 1156806, 1159109, 1163909, 1164631, 1171366, 1176114, 1182094, 1182097 |
| Expiration dates | 2025-02-28, 2025-03-31, 2025-08-31, 2025-10-31, 2026-02-28, 2026-05-31, 2026-08-31, 2027-02-28, 2027-07-31 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0285-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.