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

Risk Statement
There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes.  For populations most at risk, which include premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics, there is a reasonable probability of adverse events such as neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall.

Affected Product:
The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. Please note that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq. The affected product information is provided in Table 1 below:

Table 1: Affected Product

DESCRIPTION OF CASES BEING RECALLED:

Otsuka ICU Medical LLC is notifying its customers, including distributors, of this recall by letter and is requesting the return of all recalled products. All customers, including distributors, should check inventory locations within their institution for the affected product in Table 1, quarantine, and discontinue use.

Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return. 

For further inquiries, please contact ICU Medical using the information provided below.

The U.S. Food and Drug Administration (FDA) has been notified of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

About Otsuka ICU Medical LLC                                                                       

Otsuka ICU Medical LLC brings together global manufacturing strength, continuous innovation and a commitment to quality to deliver critical IV solutions for healthcare providers. With a broad portfolio of injectable, irrigation and parenteral nutrition products, the company is focused on building a resilient supply chain and advancing smarter, stronger patient care. Learn more at www.otsukaicumed.com.

Contact:
Consumers
ICU Medical, Inc.
1-844-654-7780

Media Contact:
Harrison Richards
ICU Medical, Inc.
949-366-4261       
[email protected] 

SOURCE Otsuka ICU Medical LLC