Regadenoson Injection — Class II drug recall D-0039-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2024-11-13, distributed nationwide. Labeling: Missing Label
| Recall number | D-0039-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-10-30 |
| Classified | 2024-11-06 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 60,594 units |
| Reason classes | labeling |
| NDC | 36000-0364, 36000-0364-01 |
| Lot numbers | 945169, 945170 |
| Expiration dates | 2025-09-25, 2025-10-24 |
Product
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01
Reason for recall
Labeling: Missing Label
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-0039-2025. 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.