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Drug FDA Class I Ongoing Mislabeling

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

Otsuka ICU Medical LLC Published Nov 26, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Otsuka ICU Medical LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

POTASSIUM CHLORIDE · 21,696 50mL flexible containers

NDC: 0990-7074, 0990-7075, 0990-7077, 0990-7074-26, 0990-7075-14, 0990-7075-26, 0990-7077-14, 0990-7077-26
Lot codes: 1030613
Code info: Lot # 1030613, Exp Date: 09/30/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 29, 2025
  2. Published
    Nov 26, 2025
Recall number
D-0180-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.