Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection after finding that some bags labeled as ordinary saline may actually contain concentrated potassium chloride, a drug that can stop a patient’s heart if pushed into the bloodstream undiluted. The affected lot, number 1042188, carries NDC 0990-7984-23 and was distributed nationwide between December 30, 2025, and June 22, 2026. No adverse events tied to the mix-up have been reported so far.
The company has not said how many of the 100-milliliter bags in that single lot are affected, only that some carry the wrong contents behind a correctly printed overwrap. Both products are manufactured on the same packaging lines at the same facility, which is how a mislabeled or misfilled bag from one product can end up shipped inside another product’s overwrap without anyone on the line noticing before it reaches a hospital shelf.
A customer complaint exposed the mix-up
The problem surfaced when a customer opened what should have been a routine saline bag and instead found a bag of Potassium Chloride Inj. 10 mEq inside the overwrap. The FDA’s recall notice says the affected saline was manufactured November 13, 2025, carries an expiration date of October 31, 2027, and was shipped to hospitals and pharmacies across the country over roughly six months before the mix-up came to light. Otsuka ICU Medical is asking anyone holding the lot to quarantine it immediately and stop using it.
In its own statement announcing the recall, the company did not soften the stakes. Otsuka ICU Medical said there is “a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes,” language reserved for the FDA’s most serious recall classifications. A company media contact, Harrison Richards, is listed on the release for reporters seeking additional detail.
The danger inside a look-alike bag
Saline and concentrated potassium chloride are both clear liquids sold in similar flexible containers, which is why hospitals rely on the printed overwrap, not the fluid itself, to tell them apart at the bedside. Pushed in as a slow, diluted infusion, potassium chloride corrects a genuine electrolyte deficiency. Pushed in rapidly or undiluted, as would happen if a nurse believed the bag was plain saline, it can trigger fatal heart rhythm disturbances within minutes, a risk the FDA said is highest for premature infants, cardiac patients and people with kidney disease.
Nothing about the outside of the bag would have tipped off hospital staff. The overwrap in the recalled lot was printed correctly as sodium chloride, meaning the only defense against a mix-up already inside a sealed package was catching it during the kind of routine open-and-inspect step that caught this one. Hospital pharmacies typically stock both products in bulk on adjacent shelving, since both are common fixtures on an IV cart, which is part of why a single misrouted bag can travel a long way through a supply chain before a nurse or pharmacist opens it and notices the contents do not match the label.
A third mix-up from the same product line in 19 months
This is not the first time Otsuka ICU Medical’s potassium chloride packaging has gone out wrong. In February 2025 the company recalled 20 mEq potassium chloride bags whose overwraps were incorrectly printed as 10 mEq. A second, nearly identical recall followed in November 2025, covering a different 20 mEq lot, numbered 1030613, that had likewise been overwrapped as 10 mEq and distributed between May 23 and August 26, 2025. Both incidents were attributed to manufacturing errors, and neither produced a reported injury.
State regulators flagged that second episode independently. A California State Board of Pharmacy alert warned pharmacists that the correct 20 mEq dosage was printed on the inner bag but hidden beneath the mislabeled overwrap, meaning a rushed check of the outer packaging alone would not catch the error.
Taken with this month’s saline recall, the three incidents span from February 2025 through September 2026 — about 19 months — and all trace back to the same 10 mEq potassium chloride product line, according to reporting that tracked the pattern across all three recalls. The first two involved potassium chloride mislabeled as a different strength of itself; this one involves a bag that should never have contained potassium chloride at all.
Otsuka ICU Medical has not said whether the three incidents share a common cause, leaving hospitals and regulators to treat each new mix-up from the line as a fresh warning rather than a resolved problem. Facilities holding lot 1042188 can reach the company’s drug safety line at 1-844-654-7780 to arrange the return, and hospitals that already administered fluid from the lot are advised to watch patients for the cardiac symptoms of a potassium overdose, including irregular heartbeat, muscle weakness and chest pain. The recall carries no reported patient harm to date, a distinction that has held across all three incidents so far even as the packaging errors keep recurring.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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