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 1 12/31/2026 2 Lot # NC185417, NC185455, Exp Date: 08/31/2027 3 Lot # NC188593, Exp Date: 11/30/2027 4 Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027 5 Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028 6 Lot # 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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