BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot: YK4W, Expiration date: 4/30/2029
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall:
CGMP Deviations; potential temperature excursions due to transit delays
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Product Codes/Lot Numbers:

Lot: YK4W, Expiration date: 4/30/2029

Distribution:

Distributed in: OH, VA, FL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0540-2025

Related Recalls