Class II

Drug Recall: Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Cardinal Health Inc. · July 30, 2025

Reason for Recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

Distribution

Nationwide Within the U.S.

States Affected

NATIONWIDE

Quantity Affected

6 units

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0571-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Cardinal Health Inc. Drug Recall: Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. | SafeCheck