FDA Drug recall D-0285-2025
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Soluti…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Soluti… by Amgen, citing stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0285-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-27 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amgen |
| Distribution | US |
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
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Identifiers
| ndc | 55513-530-01 |
|---|---|
| ndc | 55513-530-10 |
| ndc | 55513-530-20 |
| ndc | 55513-546-01 |
| ndc | 55513-546-10 |
| ndc | 55513-546-20 |
| ndc | 55513-924-01 |
| ndc | 55513-924-10 |
| ndc | 55513-924-91 |
| ndc | 55513-924-20 |
| ndc | 55513-209-01 |
| ndc | 55513-209-10 |
| ndc | 55513-209-91 |
| ndc | 55513-209-20 |
| code_info | Lot #: 1147300, 1147300A, Exp.: 2/28/2025; 1152064, Exp.:3/31/2025; 1154734, 1156806, Exp.: 8/31/2025; 1159109, Exp.: 1…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0285-2025%22
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