Class IOngoing

POTASSIUM CHLORIDE Inj. recall

FDA recall D-0180-2026 · initiated Oct 29, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

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
Recalling company: Otsuka ICU Medical LLC
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: US Nationwide.
Initiated: Oct 29, 2025
FDA report date: Nov 26, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0180-2026 ↗

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