RECOMBINATE Antihemophilic Factor Recall: Temperature Exposure Risk
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.
Lower-risk recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/31918-recombinate-antihemophilic-factor-recall-temperature-exposure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31918-recombinate-antihemophilic-factor-recall-temperature-exposure-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0573-2025
Cite this page
“RECOMBINATE Antihemophilic Factor Recall: Temperature Exposure Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31918-recombinate-antihemophilic-factor-recall-temperature-exposure-risk. Based on FDA recall #D-0573-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for vials with NDC code 00944-2843-01 and lots TRB23802AC (expires 03/18/2026) or TRA22804AA (expires 10/18/2025).
- Brand
Takeda Pharmaceuticals USA- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide Within the U.S.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0571-2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.; Lot: 3617756, Expires: 12/31/2025. | 6 units | 50242-040-62, 50242-040-86, 50242-214-01, 50242-214-86, 50242-214-03, 50242-214-55, 50242-214-99, 50242-214-83, 50242-215-86, 50242-215-01, 50242-215-03, 50242-215-55, 50242-215-99, 50242-215-83, 50242-227-01, 50242-227-55, 50242-227-99, 50242-227-86 |
| D-0572-2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55; Lot: 3630004, Expires: 10/31/2025. | 4 units | 50242-040-62, 50242-040-86, 50242-214-01, 50242-214-86, 50242-214-03, 50242-214-55, 50242-214-99, 50242-214-83, 50242-215-86, 50242-215-01, 50242-215-03, 50242-215-55, 50242-215-99, 50242-215-83, 50242-227-01, 50242-227-55, 50242-227-99, 50242-227-86 |
| D-0573-2025 | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01; Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025 | 3 units | — |
What to do — step by step
Check Product Lot Number
Look for lot numbers TRB23802AC or TRA22804AA on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Within the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0573-2025 (July 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0573-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.