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.
What this means for you
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
- missing-label
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.
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