Sodium Chloride Injection, Solution
FDA Recall NDC 0264-1800
Latest: Class I · Status: Ongoing · Initiated Aug 19, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Chloride (NDC 0264-1800). A significant event, classified as Class I, was initiated on Aug 19, 2026 by B. Braun Medical Inc.. The reported reason for this action was: "Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene"
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
Class I Ongoing
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Aug 19, 2026
Sep 16, 2026
201,472 total container
Recall Profile & Regulatory Data
Event ID
99703
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Batch or Lot Expiration Information
Lot# : J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Affected Packages Involved in this Recall
0264-1800-36Sodium Chloride
0264-1800-31Sodium Chloride
0264-1800-32Sodium Chloride
Class I Terminated
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Nov 21, 2013
May 07, 2014
53,592 units
Recall Profile & Regulatory Data
Event ID
66913
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Spain
Termination Date
Dec 04, 2014
Product Description
0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31
Batch or Lot Expiration Information
Lot# J2P912, Exp 02/14
Affected Packages Involved in this Recall
0264-1800-36Sodium Chloride
0264-1800-31Sodium Chloride
0264-1800-32Sodium Chloride
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.
