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Class I · Most seriousActive recall

Potassium Chloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # 1030613, Exp Date: 09/30/2026
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byICU Medical Inc.
Brand namePOTASSIUM CHLORIDE
Generic namePOTASSIUM CHLORIDE
Active ingredient(s)POTASSIUM CHLORIDE
Distributed by / forOtsuka ICU Medical LLC
NDC0990-7077-14
Show the full FDA record
Full product labelPOTASSIUM 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 firmOtsuka ICU Medical LLC
DistributionUS Nationwide.
Quantity21,696 50mL flexible containers
Recall initiated2025-10-29
Report date2025-11-26
Recall completed—
Recall numberD-0180-2026
ClassificationClass I
FDA statusOngoing
Origin on fileAustin TX United States

Related

Potassium chloride recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.