Cardinal Health recalls RECOMBINATE antihemophilic factor vials due to temperature exposure during storage. Affected lots expire 03/18/2026 and 10/18/2025. Contact Takeda for details.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health is recalling RECOMBINATE antihemophilic factor vials that may have been exposed to improper temperatures. This could affect the product's safety and effectiveness if used without proper storage.
The product was exposed to temperatures outside its labeled storage requirements during manufacturing. This could lead to reduced effectiveness or potential safety issues if the product is used without proper temperature control.
People with prescription antihemophilic factor (Factor VIII) who use RECOMBINATE vials from the specified lots. Those storing the product in uncontrolled environments are at higher risk.
Check for vials with NDC code 00944-2843-01 and lots TRB23802AC (expires 03/18/2026) or TRA22804AA (expires 10/18/2025).
Look for lot numbers TRB23802AC or TRA22804AA on the vial label.
Cardinal Health recalls RECOMBINATE antihemophilic factor vials that may have been exposed to improper temperatures during storage.
Check for vials with NDC code 00944-2843-01 and lots TRB23802AC (expires 03/18/2026) or TRA22804AA (expires 10/18/2025).
The recall does not specify a remedy, so contact Takeda Pharmaceuticals USA for further instructions.
We’ve drafted a message you can send Takeda Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0573-2025 — Takeda Pharmaceuticals USA Takeda Pharmaceuticals USA Hello, I own a Takeda Pharmaceuticals USA that is covered by recall D-0573-2025 from Takeda Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
