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RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals U...

FDA Recall #D-0573-2025 — Class II — July 30, 2025

Recall #D-0573-2025 Date: July 30, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Cardinal Health Inc. — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3 units

Distribution

Nationwide Within the U.S.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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