Recall: D-0813-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-06Initiated

OngoingStatus

Baxter Healthcare CorporationFirm

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

Distribution

US Nationwide; Puerto Rico; and Chile.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.