Recalls / Class II
Class IID-0540-2025
Product
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
- Brand name
- Benlysta
- Generic name
- Belimumab
- Active ingredient
- Belimumab
- Route
- Subcutaneous
- NDCs
- 49401-088, 49401-102, 49401-101
- FDA application
- BLA761043
- Affected lot / code info
- Lot: YK4W, Expiration date: 4/30/2029
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- GlaxoSmithKline LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 3 Vials
- Distribution pattern
- Within the U.S - OH, VA, FL.
Timeline
- Recall initiated
- 2025-04-21
- FDA classified
- 2025-07-21
- Posted by FDA
- 2025-07-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0540-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.