Class II
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.
CGMP Deviations
- Recall number
- D-0813-2026
- Report date
- September 9, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Baxter Healthcare Corporation
- Generic names
- NICARDIPINE HYDROCHLORIDE
- Brand names
- CARDENE IV
- Product NDCs
- 43066-009, 43066-016
Code and lot information
Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
Distribution
US Nationwide; Puerto Rico; and Chile.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.