Benlysta recall: CGMP Deviations
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Why was Benlysta recalled?
CGMP Deviations; potential temperature excursions due to transit delays
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: YK4W, Expiration date: 4/30/2029
- Product
- BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 3 Vials
- Distribution
- Within the U.S - OH, VA, FL.
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)