FDA recall D-0180-2026

Otsuka ICU Medical LLC · Class I · drug

Product

POTASSIUM 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

Reason for recall

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

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2025-10-29
Report date: 2025-11-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0180-2026