Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amgen, Inc., originally initiated on 02-27-2025 for the 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). The product was recalled due to stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0285-2025 | 02-27-2025 | 03-26-2025 | Class II | 313,620 Vials | 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). | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Ongoing |
| D-0286-2025 | 02-27-2025 | 03-26-2025 | Class II | 258,750 Vials | 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). | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 55513-209 | Neupogen | Filgrastim | Injection, Solution | Intravenous; Subcutaneous | Amgen, Inc | Human Prescription Drug |
| 55513-530 | Neupogen | Filgrastim | Injection, Solution | Intravenous; Subcutaneous | Amgen, Inc | Human Prescription Drug |
| 55513-546 | Neupogen | Filgrastim | Injection, Solution | Intravenous; Subcutaneous | Amgen, Inc | Human Prescription Drug |
| 55513-924 | Neupogen | Filgrastim | Injection, Solution | Intravenous; Subcutaneous | Amgen, Inc | Human Prescription Drug |
