POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container

Otsuka ICU Medical LLC has recalled POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 26, 2025 and was initiated on October 29, 2025. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, with approximately 21,696 50mL flexible containers affected. The company behind the recall is Otsuka ICU Medical LLC, based in Austin, TX. The FDA describes the product as: “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”

Why was POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container recalled?

According to the FDA, the stated reason for the recall is: “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 should you do?

If you think you may have bought POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, compare it against the product description and identifying codes (Lot # 1030613, Exp Date: 09/30/2026) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Otsuka ICU Medical LLC or your local health authority.

About this recall

This recall was distributed in TX. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.