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Drug FDA Class II Ongoing cGMP deviation

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

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)

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

3 units

Lot codes: TRB23802AC
Code info: Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 30, 2025
  2. Published
    Aug 13, 2025
Recall number
D-0573-2025
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.