FDA Recall D-0572-2025
Cardinal Health Inc. · Dublin, OH
Class II Ongoing 288 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Recall record
- Recall number
D-0572-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide Within the U.S.
- Recall initiated
- 2025-07-30
- Classified by FDA Center
- 2025-08-07
- FDA published
- 2025-08-13
- Recalling firm
- Cardinal Health Inc.
- Firm location
- Dublin, OH
Drug identification
- Brand name(s)
- XOLAIR
- Generic name(s)
- OMALIZUMAB
- Manufacturer(s)
- Genentech, Inc.
- NDC(s)
50242-040, 50242-214, 50242-215, 50242-227- Route(s)
- SUBCUTANEOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.