# FDA recall D-0650-2021

> **Genentech Inc** · Class II · drug recall initiated 2021-06-09.

## 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.

## Distribution

Product was distributed nationwide

## Key facts

- **Recall number:** D-0650-2021
- **Recalling firm:** Genentech Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-06-09
- **Report date:** 2021-07-14
- **Termination date:** 2022-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South San Francisco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2021

## Citation

> AI Analytics. FDA recall D-0650-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0650-2021. Source: US FDA. Licensed CC0.

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