Baxter Healthcare Corporation recalls Nexterone
- Recalling company
- Baxter Healthcare Corporation
- Product
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
- Reason
- CGMP Deviations
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 6, 2026
- Reported
- Sep 9, 2026
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- 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, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0814-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0814-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.