Sodium Chloride Injection, Solution
FDA Recall NDC 65219-328

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

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 65219-328). 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.

Reported Recall Events

D-0432-2026ONGOING

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0432-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Mar 11, 2026
Reported
Apr 15, 2026
Quantity
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
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
Batch or Lot Expiration Information
Batch# 23DU10004, Exp Date: 04/30/2026
Batch# 23HU10006, Exp Date: 06/30/2026.
Affected Packages Involved in this Recall
65219-432-20Product
65219-432-85Product
65219-328-10Product
65219-328-50Product

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.