FDAFDA recall D-0813-2026 · Sep 9, 2026
Baxter Healthcare Corporation: CARDENE IV (Nicardipine Hydrochloride) in 0 recall
Recall found
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 for recall
CGMP Deviations
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Quantity
- N/A
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-06
Source: openFDA enforcement record D-0813-2026 · search recall number D-0813-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.