FDA recall D-0571-2025

Cardinal Health Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide Within the U.S.

Key facts

Status
Ongoing
Initiation date
2025-07-30
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0571-2025