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

U.S. Food and Drug Administration sent this bulletin at 09/29/2026 10:55 PM EDT

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US Food and Drug Administration

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

**CVM is sharing these announcements because these products may be used in veterinary settings.**

September 29, 2026

ISSUE: Otsuka ICU Medical is recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL single pack due to a potential mix-up. The affected lot of 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% Sodium Chloride Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be Potassium Chloride Injection 10 mEq, (NDC 0990-7074-26) Lot 1035181. The issue has been 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.

Risk Statement:  There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall.

Adverse reactions or quality problems experienced with the use of this product in an off label manner for animal/veterinary patients may be reported to the FDA online at http://www.FDA.gov/reportanimalAE

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