Otsuka ICU Medical Recalls Potentially Contaminated Sodium Chloride Injection
News related to:Otsuka ICU Medical LLC · 1 min read
Otsuka ICU Medical LLC has issued a voluntary nationwide recall of a specific lot of 0.9% Sodium Chloride Injection, USP due to a potential mix-up. The affected lot, identified as 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23 Lot 1042188), may contain the overwrap with labeling indicating it to be 0.9% Sodium Chloride Injection, USP, but the actual product within the overwrap may be 10 mEq Potassium Chloride Injection (NDC 0990-7074-26) Lot 1035181.
The issue was identified through a customer complaint where a 10 mEq Highly Concentrated Potassium Chloride Injection 100 mL bag was found inside an overwrap of 0.9% Sodium Chloride Injection, USP 100 mL. The affected product lot was manufactured on November 13, 2025, and distributed in the United States between December 30, 2025, and June 22, 2026.
The company 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 and 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.
The U.S. Food and Drug Administration (FDA) has been notified of this action. Consumers and healthcare providers are advised to be vigilant and check their inventory for the affected product. The FDA encourages the reporting of any adverse reactions or quality problems experienced with the use of this product through its MedWatch Adverse Event Reporting program.
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.