FDA Drug · D-0181-2026

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Class I · Ongoing

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 lots / codes — check yours against thisLot # 1030613, Exp Date: 09/30/2026

Recalling firm: Otsuka ICU Medical LLC, Austin, TX
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: —
Distribution: US Nationwide.
Recall initiated: October 29, 2025
Classified: November 24, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0181-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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