FDA Recall D-0267-2025

ICU Medical, Inc. · Lake Forest, IL

Class I — life-threatening Ongoing 455 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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

Lot / code: Lot 1023172, Exp Date: 31 January 2026

Quantity: 67,488 flexible containers

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.

Recall record

Recall number: D-0267-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-02-13
Classified by FDA Center: 2025-03-10
FDA published: 2025-03-19
Recalling firm: ICU Medical, Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): POTASSIUM CHLORIDE
Generic name(s): POTASSIUM CHLORIDE
Manufacturer(s): ICU Medical Inc.
NDC(s): 0990-7074, 0990-7075, 0990-7077
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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