Prolia Injection
FDA Recall NDC 55513-710
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 Prolia (NDC 55513-710). A significant event, classified as Class II, was initiated on Apr 21, 2025 by Amgen, Inc. The reported reason for this action was: "CGMP Deviations; potential temperature excursions due to transit delays"
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
April 2025 Class II Recall: CGMP Deviations; potential temperature excursions due to transit delays
Recall Number
Class II Ongoing
CGMP Deviations; potential temperature excursions due to transit delays
Apr 21, 2025
Jul 30, 2025
6 Pre-filled syringes
Recall Profile & Regulatory Data
Event ID
97110
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the U.S - OH, VA, FL.
Product Description
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Batch or Lot Expiration Information
Lot# Lot: 1180924, Expiration date: 6/30/2027.
Affected Packages Involved in this Recall
55513-710-01Product
55513-710-21Product
Class II Terminated
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Sep 17, 2013
Nov 13, 2013
4,163 prefilled syringes
Recall Profile & Regulatory Data
Event ID
66318
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amgen, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Termination Date
Jun 02, 2014
Product Description
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.
Batch or Lot Expiration Information
Lot# : 1037592, Exp 07/15
Affected Packages Involved in this Recall
55513-710-01Product
55513-710-21Product
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.
