Xolair recall: CGMP Deviations
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Why was Xolair recalled?
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 3630004, Expires: 10/31/2025.
- Product
- Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 4 units
- Distribution
- Nationwide Within the U.S.
- Recall date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)