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Class II · ModerateActive recall

Nexterone

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 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 it was soldUS Nationwide; Puerto Rico; and Chile.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in the USA
Brand nameNEXTERONE
Generic nameAMIODARONE HYDROCHLORIDE
Active ingredient(s)AMIODARONE HYDROCHLORIDE
Distributed by / forBaxter Healthcare Corporation
NDC43066-360-20
Show the full FDA record
Full product labelNexterone (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.
Recalling firmBaxter Healthcare Corporation
DistributionUS Nationwide; Puerto Rico; and Chile.
QuantityN/A
Recall initiated2026-08-06
Report date2026-09-09
Recall completed—
Recall numberD-0814-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDeerfield IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.