Potassium chloride (KCl) injections are used to treat and prevent low blood potassium levels, a condition known as hypokalemia. The medication is administered intravenously in hospitals and medical centers to patients unable to take potassium supplements orally, or when rapid potassium replacement is needed.
The company explained that the affected batch, number 1030613 with an expiration date of September 30, 2026, has incorrect outer packaging that identifies the product as Potassium Chloride Injection 10 mEq (NDC 0990-7074-26), while the correct dosage is 20 mEq. The correct dosage is printed on the label affixed directly to the product pouch. However, this label is not visible when the product is used due to the incorrect outer packaging, which could lead to an overdose of potassium and consequently hyperkalemia, a dangerously high level of potassium that can cause:
Neuromuscular dysfunction, including muscle weakness or paralysis.
Lethargy or confusion.
Low blood pressure.
Heart rhythm disorders.
Cardiac arrest.
Most vulnerable groups
Premature babies.
Patients receiving chronic intravenous nutrition.
Individuals with a history of heart rhythm disorders.
Patients suffering from kidney dysfunction or failure.
Healthcare professionals and facilities that have the affected batch should immediately check the inventory, quarantine any affected product, and follow recall instructions.
Continuous cardiac monitoring and testing of blood potassium levels are recommended during use, and the drug should be injected slowly to avoid a sudden increase in blood potassium levels.
Batch number 1030613 can be found in the upper left corner of the product packaging or on the box label.
The affected batch was manufactured on April 15, 2025, and distributed in the United States between May 23 and August 26, 2025.
So far, the company has not received any reports of side effects related to this issue.
Potassium chloride injections have been used medically since the 1950s, while the substance itself has been used commercially as a fertilizer since 1861.
The product is a highly concentrated, ready-to-use formula, designed for patients who need potassium supplementation with limited fluid intake.
