Nexterone Injection, Solution
FDA Recall NDC 43066-150
Latest: Class II · Status: Ongoing · Initiated Aug 06, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nexterone (NDC 43066-150). A significant event, classified as Class II, was initiated on Aug 06, 2026 by Baxter Healthcare Corporation. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Aug 06, 2026
Sep 09, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide; Puerto Rico; and Chile.
Product Description
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Batch or Lot Expiration Information
Lot# NC177832, Exp Date: 12/31/2026
Lot# NC185417, NC185455, Exp Date: 08/31/2027
Lot# NC188593, Exp Date: 11/30/2027
Lot# NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027
Lot# NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028
Lot# NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
Affected Packages Involved in this Recall
43066-150-10Nexterone
43066-360-20Nexterone
Class I Terminated
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Nov 10, 2017
Feb 07, 2018
35,628 single-dose containers
Recall Profile & Regulatory Data
Event ID
78531
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within USA and Puerto Rico
Termination Date
Aug 29, 2018
Product Description
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Batch or Lot Expiration Information
Lot# Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Affected Packages Involved in this Recall
43066-150-10Nexterone
43066-360-20Nexterone
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
