Otsuka ICU Medical LLC is recalling one lot of 0.9% Sodium Chloride Injection, USP, after a customer found a bag of concentrated potassium chloride inside an outer wrap labeled as saline, according to the company's recall notice. The recall covers lot 1042188 (NDC 0990-7984-23), sold as 100 mL flexible containers with an expiration date of Oct. 31, 2027. The company announced the action on Sept. 17 and said it has received no reports of adverse events.
The product is a hospital IV fluid, not a consumer item, and the recall extends to the user level, meaning the hospitals, clinics, and other facilities that stock and give it to patients. According to the notice, some bags in the lot may carry a saline overwrap while the bag inside is Potassium Chloride Injection 10 mEq (NDC 0990-7074-26), lot 1035181.
The concern is specific. Saline is among the most routinely used fluids in medicine, often given to hydrate patients or to carry other drugs into a vein. Potassium chloride is a concentrated electrolyte that clinicians dose deliberately and monitor closely.
Lot 1042188, the Wrong Bag, and How It Was Caught
The affected saline lot was manufactured on Nov. 13, 2025, and distributed in the United States between Dec. 30, 2025, and June 22, 2026. The notice lists the case barcode as (01)30309907984231.
The problem came to light through a customer complaint. A facility found a 100 mL bag of 10 mEq potassium chloride inside a 0.9% sodium chloride overwrap, the outer pouch that protects an IV bag until use.
One detail matters for bedside safety. The company says the potassium chloride bag carries its own label clearly identifying it as potassium chloride, so the error is visible once the overwrap comes off and the inner bag is read. Photos released with the notice show a label example, the correct overwrap, and the incorrect bag inside a saline overwrap.
The notice does not say how many bags in the lot are affected or how the mix-up happened during packaging. The company said the FDA has been notified. Company recall announcements typically appear on the FDA's recalls and safety alerts listing, and the agency assigns a recall classification later.
Hospitals Told to Check Inventory, Quarantine, and Return
Otsuka ICU Medical is notifying customers, including distributors, by letter and asking for the return of all recalled product. Facilities are instructed to check every inventory location for lot 1042188, quarantine the product, and stop using it.
After a facility submits the company's response form, ICU Medical Customer Service will contact it to arrange a return label and instructions. Product complaints go to Global Complaint Management at 1-866-216-8806, and adverse event reports go to Drug Safety at 1-844-654-7780. Medical questions can be directed to Medical Information at 1-800-241-4002, option 6, and questions about product credit or returns to Customer Care at 1-800-258-5361.
Adverse reactions or quality problems can also be reported to the FDA's MedWatch program online, by mail, or by fax. RTTNews also reported the recall on Sept. 18.
Checking the label on the inner bag, not only the overwrap, is the safeguard the company's own description points to. Because the potassium chloride bag is clearly labeled, that final check before hanging a fluid is where this kind of error can be stopped.
Patients at Higher Risk and the Limits of the Recall
The company's risk statement says there is a reasonable probability that inadvertent injection of "highly concentrated potassium chloride results in adverse events and potentially fatal outcomes." The groups it lists as most at risk are premature infants, people on long-term IV nutrition, patients with a history of heart rhythm problems, people with chronic kidney insufficiency or acute kidney failure, and patients taking potassium-sparing diuretics.
For those patients, the notice lists possible effects including muscle weakness, ascending paralysis, listlessness, vertigo, confusion, low blood pressure, irregular heart rhythms, or death from cardiac arrest. None of these has been reported in connection with this lot.
The scale is limited. This is one lot of one product size, not a recall of the company's saline line, and nothing in the notice points to a supply shortage. MedicalDaily has reported that other manufacturers, including B. Braun and Baxter, recalled separate saline lots this summer for particulate matter, but those actions involve different products and a different defect.
This is not the company's first overwrap labeling problem. On Oct. 31, 2025, Otsuka ICU Medical recalled one lot of 20 mEq potassium chloride injection because its overwrap wrongly identified the product as 10 mEq. That earlier recall involved a different product and lot, and the company has not linked the two.
Patients generally cannot check this product themselves. People who received IV fluids in a hospital this year do not need to act on this notice alone, since no adverse events have been reported. Anyone with questions about their care can ask their health care team, and new muscle weakness, a racing or irregular heartbeat, or sudden confusion always warrants prompt medical attention.
The FDA may post the company announcement and later list a recall classification in its weekly enforcement reports. MedicalDaily will update this report if the agency publishes the notice, the company revises the lot information, or any adverse events are reported.
One saline lot, 1042188, is being pulled because some bags may actually contain potassium chloride. Hospitals are being told to quarantine and return it, and reading the inner-bag label remains the practical safeguard.
Key Questions Answered
What is being recalled?
Otsuka ICU Medical is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, lot 1042188, NDC 0990-7984-23. The lot expires Oct. 31, 2027.
Why was it recalled?
A customer found a 10 mEq potassium chloride bag inside an overwrap labeled as saline. Other bags in the lot may have the same mix-up.
Has anyone been harmed?
The company says it has received no reports of adverse events. It has not said how many bags may be affected.
Who faces the greatest risk if the wrong bag were given?
Premature infants, patients on long-term IV nutrition, people with heart rhythm problems or kidney failure, and those taking potassium-sparing diuretics face the highest risk. Effects could include muscle weakness, irregular heart rhythms, or cardiac arrest.
What are hospitals told to do?
Facilities should check all inventory for lot 1042188, quarantine it, stop using it, and return it to the company. The potassium chloride bag carries its own label, so reading the inner bag before use can catch the error.
Do patients need to do anything?
This is a hospital product, and patients cannot check it themselves. People with questions about care they received can ask their health care team.
