Class II · Moderate risk
Neupogen (filgrastim)
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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).
Affected NDCs
55513-0546-01
55513-0546-10
Compare with the code on your package — it is the most precise check available.
Drug: Filgrastim
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Neupogen Filgrastim NDC 55513-0546 |
480 ug/1.6mL | Injection, Solution Intravenous|subcutaneous |
Amgen, Inc | Rx |
- Recalling firm
- Amgen, Inc.
- NDC code
- 55513-546-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0286-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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