Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations
| Brand name | CARDENE IV |
| Generic name | NICARDIPINE HYDROCHLORIDE |
| Active ingredient(s) | NICARDIPINE HYDROCHLORIDE |
| Distributed by / for | Baxter Healthcare Corporation |
| NDC | 43066-016-10 |
| Full product label | 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. |
| Recalling firm | Baxter Healthcare Corporation |
| Distribution | US Nationwide; Puerto Rico; and Chile. |
| Quantity | N/A |
| Recall initiated | 2026-08-06 |
| Report date | 2026-09-09 |
| Recall completed | — |
| Recall number | D-0813-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Deerfield IL United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗