Sodium Chloride Injection, Solution
FDA Recall NDC 65219-474

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 65219-474). 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-0427-2026ONGOINGD-0426-2026ONGOINGD-0425-2026ONGOINGD-0428-2026ONGOING

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0427-2026
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, (2,250 mg per 250 mL) (9 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: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
Batch or Lot Expiration Information
Batch# 23SU10008, Exp Date: 12/31/2026
Batch# 24JU10003, Exp Date: 07/31/2027
Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027
Batch# 6402273, 6402275, Exp Date: 01/31/2028
Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028
Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028
Batch# 6402516, Exp Date: 05/31/2028.
Affected Packages Involved in this Recall
65219-466-05Product
65219-466-60Product
65219-468-05Product
65219-468-50Product
65219-470-05Product
65219-470-30Product
65219-472-05Product
65219-472-20Product
65219-474-05Product
65219-474-10Product

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0426-2026
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, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Batch or Lot Expiration Information
Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027
Batch# 6402305, 6402398, Exp Date: 02/28/2027
Batch# 6402467, Exp Date: 04/30/2027
Batch# 6402577, 6402578, Exp Date: 06/30/2027.
Affected Packages Involved in this Recall
65219-466-05Product
65219-466-60Product
65219-468-05Product
65219-468-50Product
65219-470-05Product
65219-470-30Product
65219-472-05Product
65219-472-20Product
65219-474-05Product
65219-474-10Product

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0425-2026
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 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Batch or Lot Expiration Information
Batch# 6402372, 6402374, Exp Date: 08/31/2026
Batch# 6402437, Exp Date: 10/31/2026.
Affected Packages Involved in this Recall
65219-466-05Product
65219-466-60Product
65219-468-05Product
65219-468-50Product
65219-470-05Product
65219-470-30Product
65219-472-05Product
65219-472-20Product
65219-474-05Product
65219-474-10Product

March 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0428-2026
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, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Batch or Lot Expiration Information
Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027
Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
Affected Packages Involved in this Recall
65219-466-05Product
65219-466-60Product
65219-468-05Product
65219-468-50Product
65219-470-05Product
65219-470-30Product
65219-472-05Product
65219-472-20Product
65219-474-05Product
65219-474-10Product

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.