Class II

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

Mckesson Medical-Surgical Inc. Corporate Office · April 21, 2025

Reason for Recall

CGMP Deviations; potential temperature excursions due to transit delays

Distribution

Within the U.S - OH, VA, FL.

States Affected

FL, OH, VA

Quantity Affected

6 Pre-filled syringes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0538-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.