Otsuka ICU Medical LLC: Drug Recall

Recall #D-0143-2026 · 10/27/2025

Class II: Risk

Recall Details

Recall Number: D-0143-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Otsuka ICU Medical LLC
Status: Ongoing
Date Initiated: 10/27/2025
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 509,360 100 mL bags

Reason for Recall

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

Product Description

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Distribution Pattern

Distributed Nationwide in the USA.

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 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

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.