Otsuka ICU Medical LLC: Drug Recall

Recall #D-0180-2026 · 10/29/2025

Class I: Dangerous

Recall Details

Recall Number: D-0180-2026
Classification: Class I
Product Type: Drug
Recalling Firm: Otsuka ICU Medical LLC
Status: Ongoing
Date Initiated: 10/29/2025
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21,696 50mL flexible containers

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

Product Description

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

Distribution Pattern

US Nationwide.

Other Recalls by Otsuka ICU Medical LLC

Class I: Dangerous 10/29/2025

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
Class II: Risk 10/27/2025

Lack of Assurance of Sterility: Potential for flexible container leaks.

View all recalls by Otsuka ICU Medical LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.