FDA Recall D-0039-2025

Baxter Healthcare Corporation · Deerfield, IL

Class II Ongoing 561 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025

Quantity: 60,594 units

Reason for recall

Labeling: Missing Label

Recall record

Recall number: D-0039-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the USA
Recall initiated: 2024-10-30
Classified by FDA Center: 2024-11-06
FDA published: 2024-11-13
Recalling firm: Baxter Healthcare Corporation
Firm location: Deerfield, IL

Drug identification

Brand name(s): REGADENOSON
Generic name(s): REGADENOSON
Manufacturer(s): Baxter Healthcare Corporation
NDC(s): 36000-364
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls