Baxter recalls Regadenoson Injection 0.4 mg/5mL syringes due to missing labels. This could lead to incorrect dosing. Affected units have specific NDC and lot numbers.
Labeling: Missing Label
Baxter is recalling Regadenoson Injection syringes because they lack labels. This could cause incorrect dosing during medical procedures. Patients and healthcare providers should check their syringes for labels before use.
Missing labels could lead to incorrect dosing during medical procedures. This might result in unsafe medication levels if the syringe is used without proper labeling.
Healthcare providers and patients using Regadenoson Injection for medical tests. Those with the specific NDC and lot numbers are most at risk.
Check for the NDC number 36000-364-01 or 36000-364-02 with lot numbers 945169 (exp. 9/25/2025) or 945170 (exp. 10/24/2025).
Look for the label on the syringe to confirm it is present. If missing, do not use.
The product is safe to use only if it has the label. Missing labels could lead to incorrect dosing.
Check the label on the syringe. If missing, do not use and contact Baxter for guidance.
Look for NDC 36000-364-01 or 36000-364-02 with lot numbers 945169 (exp. 9/25/2025) or 945170 (exp. 10/24/2025).
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall D-0039-2025 — Baxter Baxter Hello, I own a Baxter that is covered by recall D-0039-2025 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
