FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter CARDENE IV nicardipine injection recalled for manufacturing quality deviations
What this means
Baxter Healthcare has recalled specific lots of CARDENE IV (nicardipine hydrochloride) injection due to deviations from manufacturing quality standards. The affected lots were distributed in the United States, Puerto Rico, and Chile.
- If your healthcare facility has received lots NC177818 (expires 12/31/2026) or NC188869 (expires 12/31/2027), stop using them immediately.
- Contact Baxter Healthcare or your supplier for return or replacement instructions.
- Consult your healthcare provider if you have questions about alternative treatments.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0813-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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