📍Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer
Baxter Healthcare Corporation has recalled specific lots of Regadenoson Injection, a prescription drug used in medical settings, because the labeling is missing from the packaging. The recall affects approximately 60,594 units distributed nationwide within the USA. Because the label is absent, healthcare providers cannot verify the medication's identity or expiration date. Read more at govinfonow.com/recall/32480-baxter-recalls-regadenoson-injection-due-to-missing-label.
“Baxter Recalls Regadenoson Injection Due to Missing Label.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32480-baxter-recalls-regadenoson-injection-due-to-missing-label. Based on FDA recall #D-0039-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0039-2025%22&limit=1).
Baxter Healthcare Corporation recalled Regadenoson Injection syringes due to missing labels, the FDA said on Oct. 30, 2024. The agency announced the Class II recall of 60,594 units distributed nationwide.
How to tell if you have it
Brand: Baxter
Product: Regadenoson Injection Syringe
NDC: 36000-364-01
Lot codes: 945169 (Exp. Date 9/25/2025), 945170 (Exp. Date 10/24/2025)
Quantity: 60,594 units
The hazard
The recall addresses labeling issues where labels are missing from the pre-filled syringes. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls include a PRO+ mattress with UDI label errors (Aug. 18, 2026), sodium chloride injection with fiberglass particulates (Aug. 17, 2026), and dextrose bags with stainless steel particles (Aug. 17, 2026). Similar recent recalls of other products include American Regent Levocarnitine Injection due to missing labels (April 16, 2026) and Sandoz Focalin XR capsules due to missing lot/expiration dates (June 1, 2026).
How to tell if you have this one
Look for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), in a 5mL Single-Dose Pre-filled Syringe manufactured by Baxter Pharmaceutical Solutions, LLC. Specifically check for NDC 36000-364-01 and Lot numbers 945169 (Exp. Date 9/25/2025) or 945170 (Exp. Date 10/24/2025).
Brand
Baxter
Category
Drug
Based on the official FDA remedy
What to do — step by step
Verify Inventory
Check your stock for Regadenoson Injection with NDC 36000-364-01 and the specific lot numbers mentioned in the recall.
Contact Supplier
Reach out to Baxter Healthcare Corporation or your distributor for instructions on how to return or dispose of the affected units.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #D-0039-2025 (October 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0039-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.