Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Is Omalizumab recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Omalizumab (3 total). Check the affected lots below.
Most common reason: Temperature excursion (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Omalizumab. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Omalizumab recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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