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), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC:…
- Recall number
- D-0571-2025
- 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), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
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