Product: Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Reason for recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated: 20250730
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated