Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot: YK4W, Expiration date: 4/30/2029
Where it was sold
Within the U.S - OH, VA, FL.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0540-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 21, 2025
- FDA report date
- Jul 30, 2025
- Quantity
- 3 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
Original FDA data
Every field from FDA enforcement report D-0540-2025, exactly as published.
Show all FDA fields
- City
- Richmond
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97110
- Address
- 9954 Maryland Drive
- Address (line 2)
- Deep Run Iii Ste. 4000
- Code information
- Lot: YK4W, Expiration date: 4/30/2029
- Postal code
- 23233
- Report date
- Jul 30, 2025
- Product type
- Drugs
- Recall number
- D-0540-2025
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product quantity
- 3 Vials
- Reason for recall
- CGMP Deviations; potential temperature excursions due to transit delays
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
- Distribution pattern
- Within the U.S - OH, VA, FL.
- Recall initiation date
- Apr 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 21, 2025