Otsuka ICU Medical LLC recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,
Recalled November 26, 2025 · FDA recall D-0180-2026 · Otsuka ICU Medical
Hazard
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq · FDA Class I
Units
21,696 50mL flexible containers
Sold at
US Nationwide.
Description
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Product
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
Manufacturer(s)
Otsuka ICU Medical LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →