Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94...
FDA Recall #D-0572-2025 — Class II — July 30, 2025
Product Description
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.
Recalling Firm
Cardinal Health Inc. — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4 units
Distribution
Nationwide Within the U.S.
Code Information
Lot: 3630004, Expires: 10/31/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated