Sodium Chloride Injection, Solution
FDA Recall NDC 63323-626
Latest: Class II · Status: Ongoing · Initiated Mar 11, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 63323-626). A significant event, classified as Class II, was initiated on Mar 11, 2026 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Lack of Assurance of Sterility"
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 II Ongoing
Lack of Assurance of Sterility
Mar 11, 2026
Apr 15, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98581
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide , Alaska, and Puerto Rico.
Product Description
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Batch or Lot Expiration Information
Batch# 6402413, Exp Date: 02/29/2028
Affected Packages Involved in this Recall
63323-626-01Sodium Chloride
63323-626-50Sodium Chloride
63323-626-02Sodium Chloride
63323-626-00Sodium Chloride
63323-626-03Sodium Chloride
63323-626-25Sodium Chloride
63323-626-04Sodium Chloride
63323-626-55Sodium Chloride
63323-626-05Sodium Chloride
63323-626-10Sodium 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.
