← FDA ENFORCEMENT
D-0571-2025Class II

Cardinal Health Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Cardinal Health Inc.
Product type
Drug
Status
Ongoing
Report date
2025-08-13
Distribution
Nationwide Within the U.S.
Firm state
OH
Product quantity
6 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Lot: 3617756, Expires: 12/31/2025.

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →