BENLYSTA for injection recalled over manufacturing violations
- Recall date
- April 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mckesson Medical-Surgical Inc. Corporate Office recalls BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
- Recall number
- D-0540-2025
- FDA classification
- Class II
- Brand / firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Sold / distributed
- Within the U.S - OH, VA, FL.
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Get recall alerts
Free email alert whenever Mckesson Medical-Surgical Inc. Corporate Office has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Mckesson Medical-Surgical Inc. Corporate Office