CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalled
Cardinal Health is recalling Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0571-2025
- FDA event ID
- 97360
- Recalling firm
- Cardinal Health, Dublin, OH
- Brand
- Xolair
- Manufacturer
- Genentech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2025
- FDA classified
- 7 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2025 | Recall initiated by company | |
| 7 Aug 2025 | Classified by FDA | +8 days |
| 13 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Product as listed by the FDA
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Where it was distributed
Nationwide Within the U.S.
Questions about this recall
Why was it recalled?
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Which lots are affected?
Lot: 3617756, Expires: 12/31/2025.
Where was it sold?
Nationwide Within the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97360This product is part of a recall event; the main page for the event is Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Cardinal Health
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
| Drug | CLASS I | Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops | Cardinal Health | Sterility | Nationwide |
Other Omalizumab recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |