Sterile Water Injection
FDA Recall NDC 0264-7385
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sterile Water (NDC 0264-7385). A significant event, classified as Class II, was initiated on Apr 02, 2026 by B. Braun Medical Inc.. The reported reason for this action was: "Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2026 Class II Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recall Number
Class II Ongoing
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Apr 02, 2026
Apr 29, 2026
24,928 bags
Recall Profile & Regulatory Data
Event ID
98693
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# J5H165, Exp Date: 31 May2028
Lot# J5E237, Exp Date: 30APR2028.
Affected Packages Involved in this Recall
0264-7385-50Product
0264-7385-60Product
August 2025 Class II Recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Recall Number
Class II Ongoing
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Aug 26, 2025
Sep 24, 2025
26,316 3000 mL bags
Recall Profile & Regulatory Data
Event ID
97477
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Batch or Lot Expiration Information
Lot# : J3L519, J3L528, Exp.: 31AUG2026
Lot# : J4C522, J4C523, Exp.:28FEB2027
Affected Packages Involved in this Recall
0264-7385-50Product
0264-7385-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
