> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Otsuka ICU Recalls Mislabeled Potassium Chloride Injection
- URL: https://www.fdaweb.com/otsuka-icu-recalls-mislabeled-potassium-chloride-injection/
- Published: 2025-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:25:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160159

Otsuka ICU Medical has recalled (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap label was incorrectly printed as 10 mEq, creating a dosing error risk. The company says the error was due to a manufacturing issue. Because the overwrap conceals the inner label, users could mistakenly administer double the intended dose if they rely on the outer label, it says.

An overdose of potassium chloride can lead to hyperkalemia, a potentially life-threatening condition that can cause cardiac arrhythmias, paralysis, hypotension, or cardiac arrest, the [company says](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due?ref=fdaweb.com). Patients most at risk include premature infants, those with renal impairment, cardiac conditions, or on potassium-sparing diuretics.

To date, Otsuka says no adverse events have been reported in connection with the mislabeled product.

Potassium chloride injection is used to treat potassium deficiency in patients who cannot take oral replacement. Because it is a highly concentrated formulation, the company emphasized that it must be administered slowly and with continuous cardiac monitoring.