PROLIA (denosumab) recall — Class II (D-0538-2025) · pharmaranks
Class IIOngoing
PROLIA (denosumab) recall
FDA recall D-0538-2025 · initiated Apr 21, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
Details
Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Recalling company
Mckesson Medical-Surgical Inc. Corporate Office
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Within the U.S - OH, VA, FL.
Initiated
Apr 21, 2025
FDA report date
Jul 30, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.