FDAFDA · Food and drugs·Recall number D-0571-2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Published August 13, 2025 · Recall initiated: July 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health Inc.
- Distributor
- Nationwide Within the U.S.
- Lot
- Lot: 3617756, Expires: 12/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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