Class II

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

Cardinal Health Inc. · July 30, 2025

Reason for Recall

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

Distribution

Nationwide Within the U.S.

States Affected

NATIONWIDE

Quantity Affected

3 units

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0573-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.