FDAFDA · Food and drugs·Recall number D-0540-2025
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Published July 30, 2025 · Recall initiated: April 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; potential temperature excursions due to transit delays
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BENLYSTA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- Within the U.S - OH, VA, FL.
- Lot
- Lot: YK4W, Expiration date: 4/30/2029
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.