FDA Drug recall D-0650-2021
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use
- FDA Drug
- Class II
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use by Genentech, citing failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0650-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-09 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Genentech |
| Distribution | US |
Product
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
Reason
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
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 No.: 3352758, Exp. Date Aug 2021; Lot No.: 3352759, Exp. Date Aug 2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2021%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.