Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

POTASSIUM CHLORIDE Inj. Recalled by Otsuka ICU Medical LLC Due to Labeling: Label Error on Declared Strength-The overwrap label...

Date: October 29, 2025
Company: Otsuka ICU Medical LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Otsuka ICU Medical LLC directly.

Affected Products

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Otsuka ICU Medical LLC

Otsuka ICU Medical LLC has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report