FDA Drugs recall ·
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only… recall
- Recall number
- D-0573-2025
- Date
- (initiated July 30, 2025)
- Company / brand
- Cardinal Health Inc.
7000 Cardinal Pl, Dublin, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Why was it recalled?
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Distribution
Nationwide Within the U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0573-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.