FDAClass IMarch 19, 2025

Potassium Chloride Inj recall: Labeling Error

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC#…

Why was Potassium Chloride Inj recalled?

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1023172, Exp Date: 31 January 2026

Product
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC#…
Recalling firm
ICU Medical, Inc.
Quantity
unknown
Distribution
Nationwide in the USA
Recall date
March 19, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls