CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report

Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalled

Baxter Healthcare is recalling Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) in Galaxy Single-Dose Container, sterile, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 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.
NDC43066-150, 43066-360
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0814-2026
FDA event ID
99500
Recalling firm
Baxter Healthcare, Deerfield, IL
Manufacturer
Baxter Healthcare Corporation
Classification
Class II
Status
Ongoing
Recall initiated
6 Aug 2026
FDA classified
28 Aug 2026
Reported
9 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

6 Aug 2026Recall initiated by company
28 Aug 2026Classified by FDA+22 days
9 Sep 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

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.

Where it was distributed

US Nationwide; Puerto Rico; and Chile.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations

Which lots are affected?

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.

Where was it sold?

US Nationwide; Puerto Rico; and Chile.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

16 other products · FDA event 99500

This product is part of a recall event; the main page for the event is Clindamycin Injection USP in 5% Dextrose, 900 mg recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIVasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium ChlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIDaptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg recalledDaptomycin In Sodium ChlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IICardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene IvBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIPantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole SodiumBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIDaptomycin, in 0.9% Sodium Chloride Injection, 500 mg recalledDaptomycin In Sodium ChlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIClindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIDexmedetomidine Hydrochloride recalled by Baxter HealthcareBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIMyxredlin, Insulin Human in 0.9% Sodium Chloride Injection/mL) recalledMyxredlinBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIFamotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidineBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIVasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium ChlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIClindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIVancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin HydrochlorideBaxter HealthcareManufacturing (CGMP) DeviationsNationwide
CLASS IIClindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide

More recalls from Baxter Healthcare

All 564
ReportedClassRecallCompanyReasonWhere
DrugCLASS IDextrose Injection, USP, 70 % recalled by Baxter HealthcareBaxter HealthcareParticulate MatterNationwide
DrugCLASS I0.9% Sodium Chloride Injection USP, Viaflex recalledSodium ChlorideBaxter HealthcareParticulate MatterIL
DeviceCLASS IIBaxter Novum IQ Syringe Pump, Loaner recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
DeviceCLASS IIBaxter Novum IQ Syringe Pump recalled by Baxter HealthcareBaxter HealthcareDevice MalfunctionNationwide
DrugCLASS IIClindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin PhosphateBaxter HealthcareManufacturing (CGMP) DeviationsNationwide

Other Amiodarone recalls

All 8
ReportedClassRecallCompanyReasonWhere
DrugCLASS IAmiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone HydrochlorideMylan InstitutionalPackaging DefectsNationwide
DrugCLASS IIIAmiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone HydrochlorideAuroMedics PharmaParticulate MatterNationwide
DrugCLASS IIIAmiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone HydrochlorideAuroMedics PharmaParticulate MatterNationwide
DrugCLASS IIIAmiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone HydrochlorideAuroMedics PharmaParticulate MatterNationwide
DrugCLASS INexterone (amiodarone HCl) Premixed Injection, 150mg recalledNexteroneBaxter HealthcareParticulate MatterNationwide