Regadenoson Injection recall
FDA recall D-0039-2025 · initiated Oct 30, 2024
Baxter Healthcare Corporation recalled Regadenoson Injection in Oct 2024 — an FDA Class II recall (D-0039-2025) because Labeling: Missing Label.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Missing Label
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 60,594 units
Details
- 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
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Oct 30, 2024
- FDA report date
- Nov 13, 2024
Frequently asked
- Was Regadenoson Injection recalled?
- Baxter Healthcare Corporation recalled Regadenoson Injection in Oct 2024 — an FDA Class II recall (D-0039-2025) because Labeling: Missing Label. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Regadenoson Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0039-2025 was: Labeling: Missing Label
- Is a recalled Regadenoson Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Regadenoson Injection are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0039-2025.