Class II

Drug Recall: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

B BRAUN MEDICAL INC · April 2, 2026

Reason for Recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

Distribution

US Nationwide.

States Affected

NATIONWIDE

Quantity Affected

24,928 bags

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0495-2026

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.