Sodium Chloride Injection, Solution
FDA Recall NDC 0264-7802

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Sodium Chloride (NDC 0264-7802). A significant event, classified as Class II, was initiated on Aug 04, 2025 by B. Braun Medical Inc.. The reported reason for this action was: "Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites."

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

D-0586-2025ONGOINGD-0491-2025ONGOINGD-0655-2022TERMINATEDD-407-2014TERMINATED

August 2025 Class II Recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Recall Number
D-0586-2025
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Initiated
Aug 04, 2025
Reported
Aug 20, 2025
Quantity
23,100 containers

Recall Profile & Regulatory Data

Event ID
97368
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Batch or Lot Expiration Information
Lot# : J5C919, Exp. 08/31/2027
Affected Packages Involved in this Recall
0264-7800-00Product
0264-7800-10Product
0264-7800-20Product
0264-7802-00Product
0264-7802-10Product

June 2025 Class II Recall: Lack of assurance of sterility

Recall Number
D-0491-2025
Class II Ongoing
Reason for Recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Initiated
Jun 16, 2025
Reported
Jul 02, 2025
Quantity
187,656 containers

Recall Profile & Regulatory Data

Event ID
97059
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Batch or Lot Expiration Information
Lot# : J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Affected Packages Involved in this Recall
0264-7800-00Product
0264-7800-10Product
0264-7800-20Product
0264-7802-00Product
0264-7802-10Product

February 2022 Class II Recall: Lack of sterility assurance

Recall Number
D-0655-2022
Class II Terminated
Reason for Recall
Lack of sterility assurance: leaking bags
Initiated
Feb 25, 2022
Reported
Mar 23, 2022
Quantity
33,742 bags

Recall Profile & Regulatory Data

Event ID
89665
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Mar 16, 2023
Product Description
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Batch or Lot Expiration Information
Lot# : J1E086, J1E204, J1E213, Exp 5/31/2023; J1H137, J1H138, Exp 6/30/2023
Affected Packages Involved in this Recall
0264-7800-00Product
0264-7800-10Product
0264-7800-20Product
0264-7802-00Product
0264-7802-10Product

November 2013 Class II Recall: Labeling

Recall Number
D-407-2014
Class II Terminated
Reason for Recall
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Initiated
Nov 27, 2013
Reported
Jan 22, 2014
Quantity
19,572 bags

Recall Profile & Regulatory Data

Event ID
67095
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US and Puerto Rico.
Termination Date
Nov 01, 2014
Product Description
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
Batch or Lot Expiration Information
Lot# Lot No. J3D548, expiry: Oct, 2015
Affected Packages Involved in this Recall
0264-7800-00Product
0264-7800-10Product
0264-7800-20Product
0264-7802-00Product
0264-7802-10Product

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.