← FDA ENFORCEMENT
D-0540-2025Class II
Mckesson Medical-Surgical Inc. Corporate Office
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Product type
Drug
Status
Ongoing
Report date
2025-07-30
Distribution
Within the U.S - OH, VA, FL.
Firm state
VA
Product quantity
3 Vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Product description
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Code / lot info
Lot: YK4W, Expiration date: 4/30/2029
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →