FDA Recalls Regadenoson Injection for Missing Label Information
Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA drug recall involving missing label information. Missing labels on a risk-of-harm product create potential for improper use or dosing, and no reported illnesses or injuries are mentioned in the source.
Plain-English summary
Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection, 0.4 mg/5 mL (NDC 36000-364-01), due to missing label information. The recall affects Lot 945169 (expiration date 9/25/2025) and Lot 945170 (expiration date 10/24/2025). Distribution was nationwide within the United States.
The missing label information prevents users from accessing critical information about the product. Regadenoson is a prescription medication administered intravenously.
Healthcare providers and facilities that have received affected lots should contact Baxter Healthcare Corporation for replacement product or revised labeling information.
The recalled product
- Product
- REGADENOSON (REGADENOSON)
- Brand
- REGADENOSON
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injection
- Hazard
- Affected units
- 60,594
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 945169
- Exp. Date 9/25/2025
- 945170
- Exp. Date 10/24/2025
UPCs (1)
- 0336000364010
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · missing label
See all →- LowLevocarnitine Injection USP Missing Label Recall
FDA (Drugs) · 2026-05-06
- HighGreenpower Recalls School Buses Due to Missing Mirror Warning Label
NHTSA · 2026-04-06
- LowCT pendant replacement kits recalled for missing a safe hand position label
FDA (Devices) · 2026-01-21
- LowCT pendant upgrades recalled for missing a safe hand position label
FDA (Devices) · 2026-01-21
- LowMammography systems recalled over a missing or incorrect X-ray warning label
FDA (Devices) · 2025-12-17
Similar recalls
- ModeratePrescription Injection Recalled Due to Missing or Peeled Labels
FDA (Drugs) · 2023-08-30
- SevereBaxter Recalls Nexterone Amiodarone Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Metronidazole Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-07-10
- SevereBaxter Recalls Famotidine Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateBaxter Recalls Fluconazole Injection Bags Due to Seal Defects
FDA (Drugs) · 2015-02-04
- SevereBaxter Recalls Fluconazole Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2017-05-24