Cardinal Health Recalls Select Xolair Auto-Injectors and Syringes

The US Food and Drug Administration (FDA) has announced a Class II drug recall involving 2 separate lots of Xolair (omalizumab injection), a biologic produced by Genentech, Inc. The affected products include the 150 mg/mL auto-injector (NDC: 50242-215-55) from lot 3617756, expiring 12/31/2025, and the 75 mg/0.5 mL pre-filled syringe (NDC: 50242-214-55) from lot 3630004, expiring 10/31/2025. A total of 10 units are affected across the 2 lots, which were distributed nationwide in the US.

The recall was initiated voluntarily by the firm Cardinal Health Inc. on July 30, 2025, after discovering the products had been exposed to temperatures outside the labeled storage requirements—an issue categorized as a Current Good Manufacturing Practice (CGMP) deviation. Such exposure may compromise the stability and efficacy of the product, posing a potential risk to patient safety. While no press release has been issued, customers were notified via letter, and the recall is currently ongoing as classified by the FDA on August 7, 2025.

Xolair (omalizumab) is a monoclonal antibody used in the treatment of moderate to severe persistent asthma in patients aged six years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen. It is also indicated for chronic idiopathic urticaria (CIU) in adults and adolescents who remain symptomatic despite antihistamine treatment. Pharmacists should ensure affected lots are removed from inventory and contact Cardinal Health for further instructions regarding product return and replacement.