FDA Drug recall D-0538-2025
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513…
- FDA Drug
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513… by Mckesson Medical Surgical Corporate Office, citing CGMP Deviations; potential temperature excursions due to transit delays.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0538-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-21 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | FL, OH, VA |
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
CGMP Deviations; potential temperature excursions due to transit delays
Identifiers
| ndc | 55513-710-01 |
|---|---|
| ndc | 55513-710-21 |
| code_info | Lot: 1180924, Expiration date: 6/30/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Mckesson Medical Surgical Corporate Office
- Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived
FDA Device · Class II · 2025-08-27 · Mckesson Medical Surgical Corporate Office - BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK
FDA Drug · Class II · 2025-07-30 · Mckesson Medical Surgical Corporate Office - EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 9…
FDA Drug · Class II · 2025-07-30 · Mckesson Medical Surgical Corporate Office - BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office - ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT
FDA Device · Class II · 2025-06-04 · Mckesson Medical Surgical Corporate Office
All Mckesson Medical Surgical Corporate Office recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0538-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.