RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceut… recall
FDA recall D-0573-2025 · initiated Jul 30, 2025
Cardinal Health Inc. recalled RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… in Jul 2025 — an FDA Class II recall (D-0573-2025) because CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3 units
Details
- Product
- RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
- Recalling company
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide Within the U.S.
- Initiated
- Jul 30, 2025
- FDA report date
- Aug 13, 2025
Frequently asked
- Was RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… recalled?
- Cardinal Health Inc. recalled RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… in Jul 2025 — an FDA Class II recall (D-0573-2025) because CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… recalled?
- Per the FDA enforcement record, the reason for recall D-0573-2025 was: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Is a recalled RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda… are affected?
- Distributed: Nationwide Within the U.S.. The recall covers these lots — Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0573-2025.