Baxter Healthcare Corporation: Cardene IV (nicardipine Hydrochloride) In 0.83% Sodium Chloride Injection, 40 Mg In
Recall Summary Baxter Healthcare is recalling CARDENE IV (a heart medication) in specific batches due to manufacturing process deviations that don't meet FDA standards. The affected product is the 40 mg/200 mL injection in GALAXY containers distributed nationwide across the U.S., Puerto Rico, and Chile. This is classified as a Class II recall, meaning the product could potentially cause adverse health effects.
- Recalling firm
- Baxter Healthcare Corporation
- Product
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
- Reason
- CGMP Deviations
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide; Puerto Rico; and Chile.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/a57e18ac-607f-4315-a593-4232e50ccf5a