Recall: D-0814-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-06Initiated

OngoingStatus

Baxter Healthcare CorporationFirm

Product

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.

Reason

CGMP Deviations

Distribution

US Nationwide; Puerto Rico; and Chile.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.