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Drug FDA Class I Ongoing Mislabeling

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

ICU Medical, Inc. Published Mar 19, 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 ICU Medical, Inc. 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. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

Affected products (1)

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

POTASSIUM CHLORIDE · 67,488 flexible containers

NDC: 0990-7074, 0990-7075, 0990-7077, 0990-7074-26, 0990-7075-14, 0990-7075-26, 0990-7077-14, 0990-7077-26, 0030990707, 3030990707
Lot codes: 1023172
Code info: Lot 1023172, Exp Date: 31 January 2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 13, 2025
  2. Published
    Mar 19, 2025
Recall number
D-0267-2025
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.