FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Nexterone amiodarone injection recalled for CGMP manufacturing deviations
What this means
Baxter Healthcare has recalled multiple lots of Nexterone (amiodarone HCI) injection due to deviations from good manufacturing practices (CGMP) during production. The affected lots were distributed nationwide, Puerto Rico, and Chile. No injuries have been reported.
- Check your facility's inventory against the affected lot numbers and expiration dates listed in the recall notice.
- Do not use affected lots; quarantine and return them to your supplier or Baxter Healthcare.
- Contact Baxter Healthcare or your distributor for replacement stock if needed.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0814-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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