Xolair — Class II drug recall D-0650-2021
Terminated recall by Genentech Inc, reported 2021-07-14, distributed nationwide. Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected a
| Recall number | D-0650-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genentech Inc, South San Francisco, CA, United States |
| Recall initiated | 2021-06-09 |
| Classified | 2021-07-06 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2022-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 88,620 prefilled |
| Reason classes | specification failure |
| NDC | 50242-0040, 50242-0040-62, 50242-0040-86, 50242-0214, 50242-0214-01, 50242-0214-03, 50242-0214-55, 50242-0214-83, 50242-0214-86, 50242-0214-99, 50242-0215, 50242-0215-01, 50242-0215-03, 50242-0215-55, 50242-0215-83, 50242-0215-86, 50242-0215-99, 50242-0227, 50242-0227-01, 50242-0227-55, 50242-0227-86, 50242-0227-99 |
| Lot numbers | 3352758, 3352759 |
| Expiration dates | 2021-08-20 |
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 for recall
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0650-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.