FDA Drug recall D-0039-2025
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Soluti…
- FDA Drug
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Soluti… by Baxter Healthcare, citing labeling: Missing Label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0039-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-30 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
Labeling: Missing Label
Identifiers
| ndc | 36000-364-01 |
|---|---|
| code_info | Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0039-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.