Potassium chloride may be hiding inside IV bags labeled saline in a nationwide recall

Otsuka ICU Medical LLC has recalled a single lot of 0.9% Sodium Chloride Injection, USP after a customer found a bag of 10 mEq Potassium Chloride Injection sealed inside an overwrap printed as saline. The Food and Drug Administration posted the voluntary nationwide recall on September 17, 2026, and the company says the actual product inside the overwrap of any bag from the lot “may be POTASSIUM CHLORIDE Inj. 10 mEq.”

Saline is the most ordinary fluid in a hospital. Concentrated potassium is one of the least forgiving, and the recall exists because a bag of the second was found wearing the packaging of the first.

Lot 1042188 and the 100 mL bag

The FDA recall notice identifies the recalled product as Lot 1042188 of 0.9% Sodium Chloride Injection, USP in a 100 mL flexible container, NDC 0990-7984-23, with an expiration date of October 31, 2027. The company says the lot was manufactured on November 13, 2025 and distributed throughout the United States between December 30, 2025 and June 22, 2026. Nothing outside that one lot number is covered. The window is long enough that some of the 100 mL bags may already have been used, and the notice gives no count of how many bags were shipped.

The discovery came from a customer complaint reporting that a concentrated potassium chloride bag was inside a sodium chloride overwrap. The company’s release repeats the complaint-driven account, and the FDA page lists the potassium product by its own NDC 0990-7074-26, Lot 1035181 and Lot 1035181, the product that the notice says was actually inside the overwrap. The notice does not say where in the process the two products were swapped. Otsuka ICU Medical reports that no adverse events have been reported to date, and the FDA page repeats that line.

What a hospital does with a bag that looks right

The recall is addressed to healthcare facilities and distributors, not to the public. Facilities are told to check inventory, quarantine any Lot 1042188 product and stop using it immediately. Questions on the field action go to [email protected]; drug safety and adverse-event reports go to 1-844-654-7780 or [email protected]; returns go through customer service at 1-800-258-5361.

A clinician who reads only the overwrap has nothing to alarm them. The label on the outside says saline, and the bag itself sits inside a sealed wrapper that staff typically open only when the fluid is about to be used. The quarantine instruction is written by lot number for that reason: nothing visible on the wrapper separates a good bag from a bad one, and the only reliable check is the lot printed on it.

Why concentrated potassium is treated as a never-event

The company’s notice states that “there is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes.” It names seven consequences: muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, and cardiac dysrhythmias or death from cardiac arrest. It singles out premature infants, patients on parenteral nutrition, and people with cardiac arrhythmias, chronic kidney disease or a prescription for potassium-sparing diuretics as the most exposed.

Hospitals have been building rules around this exact drug for decades. A 1987 report in the Anesthesia Patient Safety Foundation newsletter by Floyd Brauer and Leslie Rendell-Baker of Loma Linda University described a patient who died after concentrated potassium chloride was injected in place of the intended drug, and recommended that pharmacies prepare diluted solutions and that concentrate be locked away from clinical areas. An Australian national safety alert on intravenous potassium chloride found the recurring errors were confusion with saline, reaching for potassium when meaning to pick something else, and mistakes in dilution, and quoted Lucien Leape of the Harvard School of Public Health calling removal of potassium from ward stock one of the best examples of a “forcing function.”

That history explains why the mix-up is treated as serious even with no harm reported. The safeguard those guidelines rely on is physical separation of concentrate from ordinary fluids, and a bag that arrives already inside saline packaging bypasses it. Fierce Pharma’s coverage of the recall notes that Otsuka ICU Medical is a joint venture between ICU Medical and Otsuka Pharmaceutical Factory that launched in May 2025 to strengthen IV solution supply, using ICU Medical’s Austin, Texas plant; the recalled lot was manufactured in November 2025, about six months after that launch.

Anyone who believes a patient was given the wrong fluid can report it through the FDA’s MedWatch program or by calling 1-888-463-6332. The unanswered question in the notice is how many bags of Lot 1042188 held potassium: the company says the actual product “may be” potassium chloride and gives no count of affected bags, only the single customer report that started it.

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

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