Class II

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

Otsuka ICU Medical LLC · October 27, 2025

Reason for Recall

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

Distribution

Distributed Nationwide in the USA.

States Affected

NATIONWIDE

Quantity Affected

509,360 100 mL bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0143-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Otsuka ICU Medical LLC Drug Recall: 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 | SafeCheck