The FDA's enforcement report dated 9 September 2026 lists a Class II recall of Nexterone (amiodarone hydrochloride) 360 mg/200 mL premixed in GALAXY single-dose containers, made by Baxter Healthcare. The stated reason is deviations from current good manufacturing practice; the recall is ongoing.
A Class II recall means use of the product may cause temporary or medically reversible adverse effects, or that serious harm is remote. The record does not describe a specific defect or any patient harm.
This is a US recall of a specific premixed product. Amiodarone itself is unaffected, and amiodarone prepared from vials remains available for arrhythmia and cardiac arrest protocols. Whether the affected product is distributed in India is not stated.
- Check whether your pharmacy stocks premixed Nexterone GALAXY bags and follow the supplier's recall notice.
- Amiodarone from standard vials is not affected.
- No change to arrest or arrhythmia protocols is needed.
- Report any adverse event with the premixed product through pharmacovigilance channels.
Why it matters
Premixed amiodarone is stocked in resuscitation areas, so pharmacy teams need to check stock.
Don't overread it
A manufacturing-practice recall is not evidence that amiodarone caused harm.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for emergency & critical care, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free