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: 36000-36

FDA recall notice · announced November 13, 2024 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide within the USA
Lot/code information: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Quantity: 60,594 units
Status: Ongoing
Products in this recall event:
- 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 Hea (D-0039-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.