US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Apr 2, 2026 (5 months ago)

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
B Braun Medical INC
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0495-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.