FDA Recall D-0286-2025

Amgen, Inc. · Thousand Oaks, CA

Class II Ongoing 441 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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).

Lot / code: 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.

Quantity: 258,750 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.

Recall record

Recall number: D-0286-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: 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.
Recall initiated: 2025-02-27
Classified by FDA Center: 2025-03-18
FDA published: 2025-03-26
Recalling firm: Amgen, Inc.
Firm location: Thousand Oaks, CA

Drug identification

Brand name(s): NEUPOGEN
Generic name(s): FILGRASTIM
Manufacturer(s): Amgen, Inc
NDC(s): 55513-209, 55513-530, 55513-546, 55513-924
Route(s): INTRAVENOUS, SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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