Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Lot numbers, UPCs & expiration codes
Lot: 3617756, Expires: 12/31/2025.
Where it was sold
Nationwide Within the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0571-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 30, 2025
- FDA report date
- Aug 13, 2025
- Quantity
- 6 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0571-2025, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97360
- Address
- 7000 Cardinal Pl
- Code information
- Lot: 3617756, Expires: 12/31/2025.
- Postal code
- 43017-1091
- Report date
- Aug 13, 2025
- Product type
- Drugs
- Recall number
- D-0571-2025
- Classification
- Class II
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 6 units
- Reason for recall
- CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
- Distribution pattern
- Nationwide Within the U.S.
- Recall initiation date
- Jul 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2025