Xolair recalled over manufacturing violations
- Recall date
- July 30, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cardinal Health Inc. recalls Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Recall number
- D-0572-2025
- FDA classification
- Class II
- Brand / firm
- Cardinal Health Inc.
- Sold / distributed
- Nationwide Within the U.S.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Get recall alerts
Free email alert whenever Cardinal Health Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Cardinal Health Inc.