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FDAFDA · Food and drugs·Recall number D-0180-2026

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

Published November 26, 2025 · Recall initiated: October 29, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
POTASSIUM CHLORIDE
Manufacturer
Otsuka ICU Medical LLC
Distributor
US Nationwide.
Lot
Lot # 1030613, Exp Date: 09/30/2026
Risk classification
Class I
Area (FDA)
drug
Country
United States

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