Omalizumab recalls

The FDA has published 3 recalls involving Omalizumab since 2021. The latest was reported on 13 Aug 2025. Most were for manufacturing (cgmp) deviations. Cardinal Health has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2021

Last 12 months0reported

Class I00% of total

Ongoing2latest 13 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 2Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why omalizumab is recalled

Manufacturing (CGMP) Deviations267%
Potency & Assay133%

Companies

Cardinal Health267%
Genentech133%

By year

2025267%
2021133%

Ongoing omalizumab recalls

2 active

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide

All omalizumab recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2025Drug	CLASS II	Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair	Cardinal Health	Manufacturing (CGMP) Deviations	Nationwide
14 Jul 2021Drug	CLASS II	Xolair (omalizumab) Injection, 150 mg/, 1 prefilled syringe recalledXolair	Genentech	Potency & Assay	Nationwide

Should you stop taking Omalizumab?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.