Xolair recalls
Xolair products have been recalled 3 times, most recently on 13 Aug 2025. The recalling company is usually Cardinal Health. The most common reason is manufacturing (cgmp) deviations.
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 monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why xolair is recalled
Companies
Product types
By year
Ongoing xolair recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
All xolair recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab) Injection, 150 mg/, 1 prefilled syringe recalledXolair | Genentech | Potency & Assay | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.