Agency classClass IIOur severity:High FDA (Drugs)·D-0813-2026·Announced 2026-09-09

Baxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling specific lots of CARDENE IV (Nicardipine Hydrochloride) injection due to CGMP deviations. The recall covers products distributed in the US, Puerto Rico, and Chile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are categorized as High severity, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling specific lots of CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection. The product is a human prescription drug administered intravenously, packaged in GALAXY Single-Dose Containers. The recall was initiated by the firm on August 6, 2026, and is currently ongoing.

The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The affected products are identified by Lot # NC177818 (Expiration Date: 12/31/2026) and Lot # NC188869 (Expiration Date: 12/31/2027). The National Drug Codes (NDC) for the affected packages are 43066-016-10 and 43066-009-10.

The affected products were distributed nationwide in the United States, as well as in Puerto Rico and Chile. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recalled lots.

The recalled product

Product: CARDENE IV (NICARDIPINE HYDROCHLORIDE)
Brand: CARDENE IV
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Prescription Injection
Hazard: cgmp-deviation
quality-control

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot # NC177818
Exp Date: 12/31/2026
Lot # NC188869
Exp Date: 12/31/2027.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Healthcare Corporation

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