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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Regadenoson Injection Recalled for Missing Labels

Agency Publication Date: November 6, 2024
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Summary

Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection (0.4 mg/5 mL), a prescription medication used during cardiac stress tests. This voluntary recall was initiated because certain single-dose pre-filled syringes may be missing their required product identification labels. Healthcare providers and pharmacies should immediately check their inventory for the affected lot numbers and contact the manufacturer or their distributor to arrange for a return.

Risk

A missing label on a pre-filled syringe can lead to dangerous medication errors, as healthcare staff may be unable to verify the drug name, strength, or concentration before administration. This could result in a patient receiving the wrong medication or an incorrect dosage.

What You Should Do

  1. This recall affects Regadenoson Injection (0.4 mg/5 mL) in 5 mL single-dose pre-filled syringes sold under NDC 36000-364-01 with lot numbers 945169 (Exp 9/25/2025) and 945170 (Exp 10/24/2025).
  2. Stop using the recalled product immediately and sequester any remaining units to ensure they are not administered to patients.
  3. Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return of any affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Firm initiated recall via letter notification.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) (5 mL)
Variants: Single-Dose Pre-filled Syringe, Rx only
Lot Numbers:
945169 (Exp 9/25/2025)
945170 (Exp 10/24/2025)
NDC:
36000-364-01

Recall #: D-0039-2025; Manufactured by Baxter Pharmaceutical Solutions, LLC; Manufactured for Baxter Healthcare Corporation.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95664
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Infusion Centers; Wholesalers; Medical Facilities
Manufactured In: United States
Units Affected: 60,594 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.