Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xolair (omalizumab) Injection Recalled by Genentech Inc Due to Failed Stability Specifications: Out of Specification results of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Genentech Inc directly.
Affected Products
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Quantity: 88,620 prefilled syringes
Why Was This Recalled?
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Genentech Inc
Genentech Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report