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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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
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