FDA Drug recall D-0540-2025
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK
- FDA Drug
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK 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-0540-2025 |
| 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
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Reason
CGMP Deviations; potential temperature excursions due to transit delays
Identifiers
| ndc | 49401-102-01 |
|---|---|
| ndc | 49401-101-01 |
| ndc | 49401-088-42 |
| ndc | 49401-088-47 |
| ndc | 49401-088-50 |
| ndc | 49401-088-01 |
| ndc | 49401-088-35 |
| ndc | 49401-088-02 |
| ndc | 49401-088-61 |
| code_info | Lot: YK4W, Expiration date: 4/30/2029 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Mckesson Medical Surgical Corporate Office recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0540-2025%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.