FDA Media Alert Detail

Drug Recall

FDA Drug Recall: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/m...

  • U.S. Food and Drug Administration
  • September 9, 2026
  • ID: D-0813-2026

Drug Enforcement Report Details

Recall NumberD-0813-2026
Recalling FirmBaxter Healthcare Corporation
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternUS Nationwide; Puerto Rico; and Chile.
StatusOngoing
Product Description

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 for Recall

CGMP Deviations

Code Information

Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.