FDA Drug Recalls

Recalls / Brands / Xolair

Xolair

3 FDA drug recalls involving brand “Xolair.

DateClassProductFirm
2025-07-30Class IIXolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 94Cardinal Health Inc.
2025-07-30Class IIXolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 5024Cardinal Health Inc.
2021-06-09Class IIXolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose PrGenentech Inc