Otsuka ICU Medical LLC, a manufacturer of IV solutions for healthcare providers, announced on Thursday that it is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up.

The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labelling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj. 10 mEq, (NDC 0990-7074-26) Lot 1035181. The issue was identified through a customer complaint where a 10 mEq Highly Concentrated POTASSIUM CHLORIDE Injection 100mL bag was found inside an overwrap of 0.9% SODIUM CHLORIDE Injection, USP 100 mL.

Otsuka ICU Medical warned there is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. For populations most at risk, including premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics, there is a reasonable probability of adverse events such as neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. To date, Otsuka ICU Medical has not received any reports of adverse events related to this recall.

The affected product lot was manufactured on November 13, 2025 and distributed in the United States between December 30 2025, and June 22, 2026. Otsuka ICU Medical noted that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq.

Otsuka ICU Medical is notifying its customers, including distributors, of this recall by letter, and is requesting the return of all recalled products. All customers, including distributors, should check inventory locations within their institution for the affected product, quarantine, and discontinue use.