BENLYSTA biologic injection recalled for potential temperature excursions
McKesson Medical-Surgical is recalling BENLYSTA (belimumab) due to potential temperature excursions during transit that may affect drug potency. The recall involves product distributed in Ohio, Virginia, and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a temperature-sensitive biologic where potential product exposure could result in reduced therapeutic effectiveness. While no illnesses or injuries are reported and the temperature excursions are potential rather than confirmed, this represents a risk-of-harm product used in immunosuppressed patients.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling BENLYSTA (belimumab) 400 mg/20 mL vials, Lot YK4W, with expiration date April 30, 2029. The product was distributed through GlaxoSmithKline (GSK).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The product may have experienced temperature excursions during transit. As a temperature-sensitive biologic, BENLYSTA could lose potency if exposed to improper storage conditions.
The affected lot was distributed within the United States in Ohio, Virginia, and Florida.
The recalled product
- Product
- BENLYSTA (BELIMUMAB)
- Brand
- BENLYSTA
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Biologic
- Hazard
- cgmp-deviation
- temperature-excursion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: YK4W
- Expiration date: 4/30/2029
Distribution
Distributed in 3 states:
- FL
- OH
- VA
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