Cardinal Health Inc. recalls Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5
Recalled August 13, 2025 · FDA recall D-0571-2025 · Cardinal Health
Hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. · FDA Class II
Units
6 units
Sold at
Nationwide Within the U.S.
Description
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →