# FDA recall D-0039-2025

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2024-10-30.

## 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

## Distribution

Nationwide within the USA

## Key facts

- **Recall number:** D-0039-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-10-30
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0039-2025

## Citation

> AI Analytics. FDA recall D-0039-2025. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-0039-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*