Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic,…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • 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.
Lot codes and dates

6 of 6 products

Products covered by this recall
#Product as published
112/31/2026
2Lot # NC185417, NC185455, Exp Date: 08/31/2027
3Lot # NC188593, Exp Date: 11/30/2027
4Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027
5Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028
6Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

7 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 3:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.