Saline injection lot recalled after potassium chloride bag found in mislabeled wrap

Otsuka ICU Medical LLC is voluntarily recalling one lot of 100-mL intravenous (IV) bags nationwide after a customer found a bag of 10 mEq Highly Concentrated Potassium Chloride Injection, 100 mL, inside an overwrap labeled as 0.9% Sodium Chloride Injection, USP, 100 mL. The recall extends to the user level, meaning health care facilities that have the affected product should remove it from use.

The affected lot, 1042188 (NDC 0990-7984-23), consists of 100-mL flexible containers with an expiration date of Oct. 31, 2027. According to the company, some units may have an overwrap labeled as 0.9% sodium chloride while the bag inside contains potassium chloride injection 10 mEq (NDC 0990-7074-26; lot 1035181).¹ The lot was manufactured Nov. 13, 2025, and distributed in the United States between Dec. 30, 2025, and June 22, 2026.²

Role of sodium chloride and potassium chloride in veterinary medicine

Fluid therapy is a mainstay of veterinary practice, used in settings ranging from rehydration to anesthesia, according to the 2024 American Animal Hospital Association (AAHA) Fluid Therapy Guidelines for Dogs and Cats.² The guidelines note that 0.9% sodium chloride has historically been the fluid of choice for hypochloremic patients with metabolic alkalosis because of its high chloride content.²

Potassium chloride is also commonly added to intravenous fluids to treat hypokalemia, which the guidelines describe as common in ill dogs and cats.² The guidelines caution that potassium supplementation should not exceed 0.5 mEq/kg/hr because rapid administration can be fatal, and that potassium-supplemented fluids should never be given as a bolus.²

Company outlines risks of the mix-up

In its recall announcement, Otsuka ICU Medical said there is a reasonable probability that accidentally injecting highly concentrated potassium chloride into a person could result in adverse events, including death. Potential effects include muscle weakness, ascending paralysis, hypotension, cardiac dysrhythmias and cardiac arrest. In humans, the company identified premature infants and people with cardiac arrhythmias or renal failure as among those at greatest risk.¹

Otsuka said it has not received any reports of adverse events related to the recall. The mispackaged bag carries its own label identifying the contents as potassium chloride injection 10 mEq, according to the company. The recall notice does not address animal patients or state whether the affected lot was distributed to veterinary practices.

Steps for customers

Otsuka ICU Medical is notifying customers, including distributors, by letter and is requesting the return of all recalled product.

“All customers, including distributors, should check inventory locations within their institution for the affected product . . . quarantine, and discontinue use,” Otsuka wrote in the recall announcement.¹ “Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return.”

Adverse events involving the product can be reported to ICU Medical Drug Safety at 1-844-654-7780 or DrugSafety@icumed.com. Adverse reactions or quality problems may also be reported to the FDA MedWatch Adverse Event Reporting program.

References

1. Otsuka ICU Medical LLC issues voluntary nationwide recall of 0.9% sodium chloride injection, USP due to a product mix-up with 10 mEq potassium chloride injection. Company announcement. US Food and Drug Administration. September 21, 2026. Accessed September 30, 2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due
2. Pardo M, Spencer E, Odunayo A, et al. 2024 AAHA fluid therapy guidelines for dogs and cats. J Am Anim Hosp Assoc. 2024;60(4):131-163. doi:10.5326/JAAHA-MS-7444