FDA Drug · D-0538-2025

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Class II · Ongoing

CGMP Deviations; potential temperature excursions due to transit delays

Affected lots / codes — check yours against thisLot: 1180924, Expiration date: 6/30/2027.

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6 Pre-filled syringes
Distribution: Within the U.S - OH, VA, FL.
Recall initiated: April 21, 2025
Classified: July 21, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0538-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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