Recalls / Class II
Class IID-0571-2025
Product
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
- Brand name
- Xolair
- Generic name
- Omalizumab
- Active ingredient
- Omalizumab
- Route
- Subcutaneous
- NDCs
- 50242-040, 50242-214, 50242-215, 50242-227
- FDA application
- BLA103976
- Affected lot / code info
- Lot: 3617756, Expires: 12/31/2025.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Genentech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 6 units
- Distribution pattern
- Nationwide Within the U.S.
Timeline
- Recall initiated
- 2025-07-30
- FDA classified
- 2025-08-07
- Posted by FDA
- 2025-08-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0571-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.