The FDA enforcement report lists an ongoing Class II recall, dated 9 September 2026, of Nexterone (amiodarone hydrochloride) 360 mg in 200 mL premixed single-dose containers from Baxter Healthcare. The stated reason is deviations from current good manufacturing practice.
A Class II recall means the FDA considers that use may cause temporary or medically reversible harm, or that serious harm is unlikely. The notice does not describe a specific clinical problem. It applies to this product as supplied in the USA; whether the affected lots reached India is not stated.
- The recall concerns one premixed intravenous amiodarone product, not amiodarone as a drug.
- Pharmacies stocking imported premixed amiodarone should check lot numbers against the FDA notice.
- No clinical harm is described in the notice.
- Patients already treated need no specific action on the basis of this notice.
Why it matters
Premixed amiodarone is used in emergencies, so supply gaps matter more than for most drugs.
Don't overread it
A manufacturing-practice recall is not a finding that the drug is unsafe.
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