🔍 RecallPedia

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

Class I - Dangerous
💊 Drugs Recalled: July 30, 2025 Cardinal Health Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: 3630004, Expires: 10/31/2025.
  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:
Cardinal Health Inc.
Reason for Recall:
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

Product Codes/Lot Numbers:

Lot: 3630004, Expires: 10/31/2025.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0572-2025

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