Otsuka ICU Medical LLC has announced a voluntary nationwide recall of one lot of its 20 mEq Potassium Chloride Injection. The recall was initiated after the company identified that the overwrap label on lot 1030613, with an expiration date of September 30, 2026, incorrectly states the product as Potassium Chloride Injection 10 mEq instead of the correct 20 mEq dosage.
The company explained that while the correct dosage is printed on the labeling attached to the product bag, this label is not visible when the incorrect 10 mEq overwrap is present. Otsuka ICU Medical LLC stated, "If the incorrect dosage on the 10 mEq overwrap is used instead of the correct 20mEq dosage printed on the product, an overdose of potassium chloride is possible." According to their notice, a potassium chloride overdose can cause hyperkalemia and lead to serious health risks such as neuromuscular dysfunction, muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or even death from cardiac arrest. Certain groups—including premature infants and patients with kidney issues or those taking potassium-sparing diuretics—are particularly at risk.
As of now, no adverse events related to this labeling issue have been reported.
Potassium Chloride Injection in both 20 mEq and 10 mEq strengths is used for treating potassium deficiency in patients who cannot take oral replacements. The company noted: "THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K+ LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. TO AVOID POTASSIUM INTOXICATION, DO NOT INFUSE THESE SOLUTIONS RAPIDLY." Patients receiving these injections should be under continuous cardiac monitoring and have frequent tests for serum potassium concentration and acid-base balance.
The affected lot was manufactured on April 15, 2025 and distributed in the United States between May 23 and August 26 of that year.
Otsuka ICU Medical LLC has notified customers and distributors about this recall by letter and is coordinating returns of all recalled products. Customers are instructed to stop using or distributing any affected inventory and return it to their place of purchase. Assistance for returns can be obtained by contacting Sedgwick at 1-888-566-2363 during business hours.
For further questions or to report complaints about this product or adverse reactions associated with IV solutions or drugs from Otsuka ICU Medical LLC, customers can use various contact options provided by the company. Adverse reactions or quality concerns may also be reported directly to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by mail/fax using forms available at www.fda.gov/MedWatch/getforms.htm.
The U.S. Food and Drug Administration (FDA) has been notified about this recall action.
