20 mEq Potassium Chloride Injection

  • Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection
  • Company: Otsuka ICU Medical LLC
  • Drugs
  • FDA
  • October 31, 2025

Product details

  • 20 mEq Potassium Chloride Injection

Company announcement

Otsuka ICU Medical LLC is recalling a mislabeled lot of Potassium Chloride Injection 20 mEq due to the overwrap incorrectly stating it as 10 mEq.

The affected product was distributed nationwide between May 23, 2025, and August 26, 2025.

No adverse events have been reported to date.

Risk:

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. Overdose of potassium chloride can lead to hyperkalemia. Hazards of severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes.

Impacted states: Nationwide

Products:

- POTASSIUM CHLORIDE Inj. 20 mEq (UPC code(s): 0990707714)

- POTASSIUM CHLORIDE Inj. 10 mEq (UPC code(s): 0990707426)

Contact

For more information, call (844) 654-7780.

View the original FDA notice

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