Class II

Drug Recall: Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

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

4 units

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0572-2025

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.