RECOMBINATE — Class II drug recall D-0573-2025
Ongoing recall by Cardinal Health Inc., reported 2025-08-13, distributed nationwide. CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
| Recall number | D-0573-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2025-07-30 |
| Classified | 2025-08-07 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling, cgmp |
| NDC | 00944-2843-01 |
| Lot numbers | TRA22804AA, TRB23802AC |
| Expiration dates | 2025-10-18, 2026-03-18 |
Product
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Reason for recall
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0573-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.