Amgen, Inc.: Drug Recall

Recall #D-0285-2025 · 02/27/2025

Class II: Risk

Recall Details

Recall Number: D-0285-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Amgen, Inc.
Status: Ongoing
Date Initiated: 02/27/2025
Location: Thousand Oaks, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 313,620 Vials

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.

Product Description

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).

Distribution Pattern

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.

Other Recalls by Amgen, Inc.

Class II: Risk 02/27/2025

Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Class II: Risk 05/02/2022

Defective container: loose crimp defect, potential loss of container integrity.

View all recalls by Amgen, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.