Agency classClass IIOur severity:Severe FDA (Drugs)·D-0814-2026·Announced 2026-09-09

Baxter Recalls Nexterone Amiodarone Injection Due to Manufacturing Deviations

Baxter Healthcare is voluntarily recalling specific lots of Nexterone (amiodarone hydrochloride) injection due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when no specific hospitalization reports are detailed but the classification indicates potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling specific lots of Nexterone (amiodarone hydrochloride) 360 mg/200 mL in GALAXY Single-Dose Containers. The recall was initiated on August 6, 2026, due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is a sterile, nonpyrogenic, iso-osmotic solution in Dextrose intended for intravenous use.

The recall covers lots distributed nationwide in the United States, as well as in Puerto Rico and Chile. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between December 2026 and May 2028. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the product if it matches the recall criteria. Consumers should consult their healthcare provider if they have received or used this medication. Baxter Healthcare is the recalling firm and is responsible for notifying customers.

The recalled product

Product: NEXTERONE (AMIODARONE HYDROCHLORIDE)
Brand: NEXTERONE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Antiarhythmic
Hazard: cgmp-deviations

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot # NC177832
Exp Date: 12/31/2026
Lot # NC185417
NC185455
Exp Date: 08/31/2027
Lot # NC188593
Exp Date: 11/30/2027
Lot # NC188647
NC188685
NC188807
NC188838
NC188920
Exp Date: 12/31/2027
Lot # NC193603
NC193726
NC193788
NC193863
NC193900
Exp Date: 04/30/2028
Lot # NC194082

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · NEXTERONE

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