FDA Drug recall D-0571-2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55
- FDA Drug
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55 by Cardinal Health, citing CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0571-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-30 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Identifiers
| ndc | 50242-040-62 |
|---|---|
| ndc | 50242-040-86 |
| ndc | 50242-214-01 |
| ndc | 50242-214-86 |
| ndc | 50242-214-03 |
| ndc | 50242-214-55 |
| ndc | 50242-214-99 |
| ndc | 50242-214-83 |
| ndc | 50242-215-86 |
| ndc | 50242-215-01 |
| ndc | 50242-215-03 |
| ndc | 50242-215-55 |
| ndc | 50242-215-99 |
| ndc | 50242-215-83 |
| ndc | 50242-227-01 |
| ndc | 50242-227-55 |
| ndc | 50242-227-99 |
| ndc | 50242-227-86 |
| code_info | Lot: 3617756, Expires: 12/31/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-08-13 · Cardinal Health - Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
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FDA Drug · Class II · 2025-05-07 · Cardinal Health - LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%)
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0571-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.