FDAFDA · Food and drugs·Recall number D-0813-2026
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.
Published September 9, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARDENE IV
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide; Puerto Rico; and Chile.
- Lot
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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