Austin, Texas – – September 19, 2026 -- Otsuka ICU Medical LLC has issued a voluntary user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, after discovering that bags labeled as saline may actually contain highly concentrated Potassium Chloride Injection.
Mislabeled overwrap conceals lethal potassium concentrate inside saline packaging
The affected lot, NDC 0990-7984-23, Lot 1042188, carries external labeling identifying it as 0.9% Sodium Chloride Injection, USP. Internally, however, the overwrap may instead contain Potassium Chloride Inj. 10 mEq (NDC 0990-7074-26, Lot 1035181), a highly concentrated formulation intended for diluted use only.
Customer complaint exposed the packaging error before wider harm occurred
The mix-up surfaced after a customer reported finding a 10 mEq Potassium Chloride Injection bag inside a Sodium Chloride overwrap. The inner bag retains its own correct label reading Potassium Chloride Inj. 10 mEq, giving clinicians a final visual check before administration.
Company warns of fatal cardiac risk for vulnerable patient groups
Otsuka ICU Medical states inadvertent injection of undiluted potassium chloride carries a reasonable probability of adverse events, including neuromuscular dysfunction, ascending paralysis, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Populations at highest risk include premature infants, patients on chronic parenteral nutrition, those with cardiac arrhythmia history, chronic or acute renal impairment, and patients on potassium-sparing diuretics. The company has not received any adverse event reports linked to the recall to date.
Nearly six months of shipments across the U.S. fall under the recall window
The affected lot was manufactured on November 13, 2025, and distributed throughout the United States between December 30, 2025, and June 22, 2026.
ICU Medical directs distributors to quarantine stock and initiate returns
Otsuka ICU Medical is notifying customers and distributors by letter, instructing them to check inventory, quarantine affected units, and discontinue use. Once customers submit a response form, ICU Medical Customer Service will coordinate return labels and shipping instructions. The FDA has been notified of the action, and adverse events can be reported through the agency's MedWatch program.