CLASS II ONGOING Drug recall · Reported 13 Nov 2024 · FDA Enforcement Report
Regadenoson Injection, 0.4 mg recalled by Baxter Healthcare
Baxter Healthcare is recalling Regadenoson Injection, 0.4 mg/ (0.08 mg/mL) Single-Dose Pre-filled Syringe, distributed nationwide in the US. The recall was initiated on 30 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0039-2025
- FDA event ID
- 95664
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Regadenoson
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2024
- FDA classified
- 6 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Oct 2024 | Recall initiated by company | |
| 6 Nov 2024 | Classified by FDA | +7 days |
| 13 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label
Product as listed by the FDA
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
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Labeling: Missing Label
Which lots are affected?
Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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