The Recall Desk
HighFDA (Drugs)·D-0285-2025·Announced 2025-03-26

Neupogen Injectable Drug Recalled for Potential Stability Issues at Expiration

Amgen is recalling Neupogen (filgrastim) injectable vials due to stability concerns. Stability data indicates the product may be out of specification at its expiration date.

What this means for you

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: This is a Class II recall for a drug that may be out of specification at expiry, representing a risk-of-harm product where patients could receive ineffective medication for serious conditions. No illnesses, injuries, or deaths have been reported, capping severity at High per the rubric.

Plain-English summary

Amgen, Inc. is recalling Neupogen (filgrastim) For Injection, 300mcg/1 mL, in 1 mL single-dose vials. The recall affects multiple lot numbers with expiration dates ranging from February 2025 to July 2027.

Stability data 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 their intended potency and effectiveness through the labeled expiration date.

This recall affects Neupogen distributed nationwide in the United States and multiple international markets. Approximately 313,620 vials have been distributed. Healthcare providers and patients should stop using affected lot numbers immediately and contact their pharmaceutical supplier or Amgen to arrange for replacement medication.

The recalled product

Product
NEUPOGEN (FILGRASTIM)
Brand
NEUPOGEN
Manufacturer
Amgen, Inc.
Category
Drug — Injectable
Hazard
Affected units
313,620

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 (20)

  • 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

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

Same brand · NEUPOGEN

Same manufacturer · Amgen, Inc.

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Same hazard · stability degradation

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