Cardinal Health Inc. 2025-08-13 Health serious FDA
Health · FDA · Recall #FDA-D-0573-2025
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… Recall
Issued August 13, 2025 · Cardinal Health Inc.
In August 2025, Cardinal Health Inc. recalled the RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
What you should do
- 1 Stop using RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cardinal Health Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cardinal Health Inc.
- Category
- Health
- Recall date
- August 13, 2025
- Units affected
- Not reported
- Sold at
- Nationwide Within the U.S.
- Recall number
- FDA-D-0573-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Cardinal Health Inc. has 8 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.