Otsuka ICU Medical Recalls Sodium Chloride Injection Lot for Potential Potassium Chloride Mix-Up
Otsuka ICU Medical LLC announced a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after a customer complaint identified a potential product mix-up. Sodium chloride overwraps from lot 1042188, NDC 0990-7984-23, may contain 10-mEq Potassium Chloride Injection bags from lot 1035181. The affected lot was manufactured on November 13, 2025, distributed in the United States from December 30, 2025, through June 22, 2026, and expires October 31, 2027. The company reported no related adverse events to date. Customers and distributors were instructed to inspect inventory, quarantine and discontinue use, and return affected product.