Neupogen Injection, Solution
FDA Recall NDC 55513-209
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Neupogen (NDC 55513-209). A significant event, classified as Class II, was initiated on Feb 27, 2025 by Amgen, Inc. The reported reason for this action was: "Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Feb 27, 2025
Mar 26, 2025
313,620 Vials
Recall Profile & Regulatory Data
Event ID
96325
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
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.
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).
Batch or Lot Expiration Information
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, Exp.:7/31/2027.
Affected Packages Involved in this Recall
55513-530-01Product
55513-530-10Product
55513-530-20Product
55513-546-01Product
55513-546-10Product
55513-546-20Product
55513-924-01Product
55513-924-10Product
55513-924-91Product
55513-924-20Product
55513-209-01Product
55513-209-10Product
55513-209-91Product
55513-209-20Product
Class II Ongoing
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Feb 27, 2025
Mar 26, 2025
258,750 Vials
Recall Profile & Regulatory Data
Event ID
96325
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
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.
Product Description
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).
Batch or Lot Expiration Information
Lot# 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 Packages Involved in this Recall
55513-530-01Product
55513-530-10Product
55513-530-20Product
55513-546-01Product
55513-546-10Product
55513-546-20Product
55513-924-01Product
55513-924-10Product
55513-924-91Product
55513-924-20Product
55513-209-01Product
55513-209-10Product
55513-209-91Product
55513-209-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
