# FDA recall D-0572-2025

> **Cardinal Health Inc.** · Class II · drug recall initiated 2025-07-30.

## Product

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

## Reason for recall

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

## Distribution

Nationwide Within the U.S.

## Key facts

- **Recall number:** D-0572-2025
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-30
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2025

## Citation

> AI Analytics. FDA recall D-0572-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0572-2025. Source: US FDA. Licensed CC0.

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