EVENITY — Class II drug recall D-0539-2025
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2025-07-30, distributed in FL, OH, VA. CGMP Deviations; potential temperature excursions due to transit delays
| Recall number | D-0539-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2025-04-21 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Distributed | FL, OH, VA |
| Quantity | 2 pre |
| Reason classes | cgmp, temperature control |
| NDC | 55513-0509, 55513-0509-01, 55513-0509-02, 55513-0880, 55513-0880-01, 55513-0880-02, 55513-0998, 55513-0998-01, 55513-0998-02 |
| Lot numbers | 1178382 |
| Expiration dates | 2027-03-31 |
Product
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Reason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0539-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.