Class IIReported 2025-07-30

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Recalled by Mckesson Medical-Surgical Inc. Corporate Office

Reason for Recall

CGMP Deviations; potential temperature excursions due to transit delays

Recall Number

D-0540-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-04-21

Reported

2025-07-30

Distribution

Within the U.S - OH, VA, FL.

Code Info

Lot: YK4W, Expiration date: 4/30/2029

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.