Injectable Drug Recalled for Stability Issues at Expiration
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where stability data does not support current expiration dates. Products have potential to be out of specification at expiry, representing a risk-of-harm to patients (particularly immunocompromised individuals) who depend on this drug maintaining full potency for treatment.
Plain-English summary
Amgen, Inc. is recalling Neupogen (filgrastim) For Injection 480 mcg/1.6 mL vials distributed nationwide and internationally. The recall affects 258,750 vials across multiple lots: 1147308, 1154183 (expiring 2/28/2025); 1156807, 1160222 (expiring 6/30/2025); 1160223, 1163912, 1167352 (expiring 2/28/2026); and 1171365, 1175057, 1176250 (expiring 11/30/2026).
The recall is based on stability testing data that does not support the current expiration dates. The products have the potential to be out of specification at the time of expiry, meaning they may not maintain intended potency or safety through their stated expiration date.
Affected product was distributed throughout the United States and to Belgium/Luxembourg, Brazil, Chile, Colombia, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, Sweden, Finland, Switzerland, United Kingdom, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, and Gibraltar.
Patients should check if their Neupogen supply includes any of the affected lot numbers listed above. Contact your healthcare provider or pharmacist immediately for guidance on affected medications. Do not use product from affected lots without consulting a healthcare professional.
The recalled product
- Product
- NEUPOGEN (FILGRASTIM)
- Brand
- NEUPOGEN
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Biologic / Injectable
- Affected units
- 258,750
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
UPCs (2)
- 0355513546102
- 0355513530101
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Amgen, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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