FDA Recall D-0538-2025
Mckesson Medical-Surgical Inc. Corporate Office · Richmond, VA
Class II Ongoing 388 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Reason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Recall record
- Recall number
D-0538-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Within the U.S - OH, VA, FL.
- Recall initiated
- 2025-04-21
- Classified by FDA Center
- 2025-07-21
- FDA published
- 2025-07-30
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Firm location
- Richmond, VA
Drug identification
- Brand name(s)
- PROLIA
- Generic name(s)
- DENOSUMAB
- Manufacturer(s)
- Amgen, Inc
- NDC(s)
55513-710- Route(s)
- SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.