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Drug FDA Class II Ongoing Failed specifications

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).

Amgen, Inc. Published Mar 26, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amgen, Inc. or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Failed Stability Specifications · primary

Affected products (1)

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).

NEUPOGEN · 258,750 Vials

NDC: 55513-209, 55513-530, 55513-546, 55513-924, 55513-530-01, 55513-530-10, 55513-530-20, 55513-546-01, 55513-546-10, 55513-546-20, 55513-924-01, 55513-924-10, 55513-924-91, 55513-924-20, 55513-209-01, 55513-209-10, 55513-209-91, 55513-209-20
Lot codes: 1147308
Code info: 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.

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 27, 2025
  2. Published
    Mar 26, 2025
Recall number
D-0286-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.