The FDA has listed an ongoing Class II recall covering Nexterone (amiodarone hydrochloride) 360 mg in 200 mL, 1.8 mg/mL, in GALAXY single-dose containers, made by Baxter Healthcare Corporation. The stated reason is deviation from current good manufacturing practice, recorded on 9 September 2026.
What that classification means matters for how this is handled. Class II is the middle tier: exposure may cause temporary or medically reversible adverse consequences, and the probability of serious harm is remote. It is a manufacturing-quality action, not a safety finding about amiodarone and not a statement that patients given these bags have come to harm. The status is listed as ongoing, which means the recall is in progress rather than completed.
The practical issue is where these bags live. Premixed amiodarone is stocked precisely because it is grabbed in a hurry — resuscitation trolleys, cardiac arrest bags, transfer kits — which are the places least likely to be checked during a routine stock sweep. Anyone who stocks this presentation should check lot numbers against the FDA recall listing and confirm that trolleys and satellite stores were included, not just the main pharmacy shelf. In India, availability of this specific presentation is limited and CDSCO is the relevant authority; ampoule amiodarone requiring dilution is unaffected.
- Check lot numbers against the FDA recall listing if your unit stocks Nexterone premixed bags
- Sweep resuscitation trolleys and transfer kits, not only pharmacy shelves
- Amiodarone ampoules requiring dilution are not covered by this recall
- Record the check, so a second sweep is not needed when someone asks
Why it matters
Recalled stock on a resuscitation trolley is the kind that gets found last and used first.
Don't overread it
A Class II manufacturing recall is a quality action — it says nothing about the safety of amiodarone as a drug.
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