BENLYSTA — Class II drug recall D-0540-2025
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-0540-2025 |
|---|---|
| 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 | 3 vials |
| Reason classes | cgmp, temperature control |
| NDC | 49401-0088, 49401-0088-01, 49401-0088-02, 49401-0088-35, 49401-0088-42, 49401-0088-47, 49401-0088-50, 49401-0088-61, 49401-0101, 49401-0101-01, 49401-0102, 49401-0102-01 |
| Lot numbers | YK4W |
| Expiration dates | 2029-04-30 |
Product
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
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-0540-2025. 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.