Otsuka ICU Medical, a joint venture from Japan’s Otsuka Pharmaceutical Factory, issued a voluntary recall of one lot of 0.9% sodium chloride injection for IV due to a possible mix-up of labels.
The lot being recalled (1042188) may be mislabeled and actually contain potassium chloride for injection. The product was produced in November 2025 and distributed nationwide in the U.S. between December 2025 and June 2026.
“There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes,” the company said in a letter posted to the FDA website.
Possible side effects from use of the mislabeled product cover neuromuscular dysfunction, including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest, according to the recall notice.
The labelling problem was identified by a customer complaint after a highly concentrated bag of potassium chloride was found inside the overwrap of sodium chloride, Otsuka ICU Medical explained.
As of Sept. 17, the company had not received any reports of adverse events related to the recall.
With broader ties to Japan-based drugmaker Otsuka Pharmaceutical, Otsuka ICU Medical was born last May as a joint venture between medical device specialist ICU Medical and Otsuka Holdings subsidiary Otsuka Pharmaceutical Factory.
The JV was forged to bolster the supply chain for IV solutions in the United States, with ICU Medical agreeing to put forward its production services in Austin, Texas, for the project.