Class IIOngoing

BENLYSTA (belimumab) for injection recall

FDA recall D-0540-2025 · initiated Apr 21, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations; potential temperature excursions due to transit delays

Details

Product: BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Recalling company: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Within the U.S - OH, VA, FL.
Initiated: Apr 21, 2025
FDA report date: Jul 30, 2025

This recall is linked to a product we cover: Benlysta →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0540-2025 ↗

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