Bags labeled as saline may hold concentrated potassium chloride instead, the FDA warns

One lot of 0.9% sodium chloride injection is the subject of a nationwide recall that the FDA posted on September 21, 2026: lot 1042188 of Otsuka ICU Medical LLC’s 100 mL single-use flexible bags, NDC 0990-7984-23. A customer complaint revealed a bag of potassium chloride injection, 10 mEq, inside an overwrap labeled as saline. The company says injecting concentrated potassium chloride by mistake could be fatal.

The mislabeling runs in one direction. According to the notice, “the actual product within the overwrap may be POTASSIUM CHLORIDE Inj. 10 mEq,” and the bag inside carries its own potassium chloride label, NDC 0990-7074-26, lot 1035181. A clinician who trusted the outer overwrap, rather than reading the inner bag, would be hanging a high-alert drug while believing it was routine IV fluid.

Potassium chloride inside a sodium chloride overwrap

The company announced the recall on September 17, and the FDA published the notice on its recalls page four days later. Otsuka ICU Medical, based in Austin, Texas, and branded as ICU Medical, says the affected lot was manufactured on November 13, 2025, expires on October 31, 2027, and was distributed only within the United States between December 30, 2025 and June 22, 2026. That leaves a stretch of nearly six months in which the lot could have reached hospital shelves and pharmacy carts.

No adverse events have been reported to the company. The notice instructs customers to quarantine the affected product, stop using it, and contact the company to arrange a return.

The timeline puts the recall well after the product moved. The last distribution date in the notice, June 22, 2026, came 87 days before the company announced the recall on September 17, and the lot had been manufactured more than ten months before that announcement. Hospitals that bought from lot 1042188 and still hold stock are the audience for the quarantine instruction, and the notice directs them to quarantine the product and contact the company.

Concentrated potassium as a high-alert drug

The notice states there is “a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes.” It singles out premature infants, patients with chronic renal failure and patients with cardiac arrhythmias as the groups at greatest risk, and it lists cardiac dysrhythmias and death from cardiac arrest among the possible effects. Veterinary trade coverage of the recall adds muscle weakness, ascending paralysis and hypotension to the list of effects the company supplied.

The Institute for Safe Medication Practices has built a long record around this one drug. In an alert on concentrated electrolyte products, ISMP wrote that “Direct IV administration of potassium chloride for injection concentrate has proven fatal.” It recommended barcode scanning, failure mode analyses of high-alert medications and keeping concentrated potassium chloride in pharmacy-only locations so that undiluted product does not reach patient care units.

The Agency for Healthcare Research and Quality’s Patient Safety Network classifies concentrated potassium chloride as a high-alert medication, one for which dosing mistakes cause particularly severe harm, and points to ISMP’s June 3, 2021 acute care alert on errors during resuscitation codes, where administration of the concentrate has led to patient deaths. Such errors persist, the resource says, because of breakdowns in team communication under stress.

ISMP and ECRI’s National Alert Network made the same point about look-alike packaging in a warning on a new 250 mL potassium chloride bag, saying the concentrate “can stop a patient’s heart if accidentally administered undiluted, resulting in a fatal outcome.” The same alert recalls a historical case in which a 250 mL glass bulk container, mistaken for dextrose 5%, was used as a diluent for heparin syringes meant for newborn umbilical lines, and three infants died.

A manufacturing mix-up rather than a pharmacy one

Those earlier warnings mostly concern concentrate in pharmacy-only containers that wandered into the wrong place. The 2026 recall describes a different failure: a 10 mEq potassium chloride bag that the notice says was found inside saline overwrap, a defect that originates before the product ever reaches a hospital. ISMP has also petitioned the FDA to set standardized labeling and packaging requirements for outsourcing facilities that match commercial manufacturer standards. Barcode scanning is among the safeguards ISMP recommends, and the recalled bag’s inner label and outer overwrap carry different product identities, so the defect rests on which of the two a person reads or scans.

Otsuka ICU Medical’s drug safety team can be reached at 1-844-654-7780 or [email protected], and its customer care line is 1-800-258-5361. The dvm360 report on the recall notes that the problem surfaced through a customer’s complaint rather than through an injury.

The notice does not say how many overwraps hold the wrong bag. It identifies one lot and one confirmed mix-up, potassium chloride lot 1035181 inside a sodium chloride overwrap, so the number of mislabeled units within lot 1042188 remains unknown to the public.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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