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Drug FDA Class II Ongoing cGMP deviation

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

Cardinal Health Inc. Published Aug 13, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cardinal Health Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

XOLAIR · 4 units

NDC: 50242-040, 50242-214, 50242-215, 50242-227, 50242-040-62, 50242-040-86, 50242-214-01, 50242-214-86, 50242-214-03, 50242-214-55, 50242-214-99, 50242-214-83, 50242-215-86, 50242-215-01, 50242-215-03, 50242-215-55, 50242-215-99, 50242-215-83, 50242-227-01, 50242-227-55, 50242-227-99, 50242-227-86
Lot codes: 3630004
Code info: Lot: 3630004, Expires: 10/31/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 30, 2025
  2. Published
    Aug 13, 2025
Recall number
D-0572-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.