Cardinal Health Inc.: Drug Recall

Recall #D-0571-2025 · 07/30/2025

Class II: Risk

Recall Details

Recall Number: D-0571-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Cardinal Health Inc.
Status: Ongoing
Date Initiated: 07/30/2025
Location: Dublin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

Reason for Recall

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

Product Description

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Distribution Pattern

Nationwide Within the U.S.

Other Recalls by Cardinal Health Inc.

Class II: Risk 08/05/2025

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 07/30/2025

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II: Risk 04/09/2025

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Class I: Dangerous 10/31/2023

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

View all recalls by Cardinal Health Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.