CLASS II ONGOING Drug recall · Reported 26 Mar 2025 · FDA Enforcement Report
Neupogen (filgrastim) For Injection, 480 mcg recalled by Amgen
Amgen is recalling Neupogen (filgrastim) For Injection, 480 mcg/ (300 mcg/ single Dose Vial, distributed nationwide in the US. The recall was initiated on 27 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0286-2025
- FDA event ID
- 96325
- Recalling firm
- Amgen, Thousand Oaks, CA
- Brand
- Neupogen
- Manufacturer
- Amgen, Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2025
- FDA classified
- 18 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 18 Mar 2025 | Classified by FDA | +19 days |
| 26 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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).
Where it was distributed
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.
Questions about this recall
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.
Which lots are affected?
Lot 1147308, 1154183, Exp.: 2/28/2025; 1156807, 1160222, Exp.: 6/30/2025; 1160223, 1163912, 1167352, Exp.: 2/28/2026; 1171365, 1175057, 1176250, Exp.: 11/30/2026.
Where was it sold?
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 should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96325This product is part of a recall event; the main page for the event is Neupogen (filgrastim) For Injection, 300mcg/ Single Dose Vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Neupogen (filgrastim) For Injection, 300mcg/ Single Dose Vials recalledNeupogen | Amgen | Potency & Assay | Nationwide |
More recalls from Amgen
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 30mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 90mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sensipar (cinacalcet) Tablets, 60mg recalled by AmgenSensipar | Amgen | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 5 mg recalled by AmgenCorlanor | Amgen | Packaging Defects | Nationwide |
| Drug | CLASS II | Corlanor (ivabradine) tablets, 7.5mg recalled by AmgenCorlanor | Amgen | Other | Nationwide |
Other Filgrastim recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Neupogen (filgrastim) For Injection, 300mcg/ Single Dose Vials recalledNeupogen | Amgen | Potency & Assay | Nationwide |