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
Recalled August 13, 2025 · FDA recall D-0572-2025 · Cardinal Health
Hazard
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. · FDA Class II
Units
4 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), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →