Sodium Chloride Injection, Solution
FDA Recall NDC 17271-701
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 17271-701). A significant event, classified as Class II, was initiated on Mar 11, 2026 by Becton Dickinson And Company. 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
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
Batch or Lot Expiration Information
Batch# 24EU10010, Exp Date: 05/31/2027.
Affected Packages Involved in this Recall
17271-701-02Product
17271-701-03Product
17271-701-05Product
17271-701-06Product
17271-701-07Product
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
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
Batch or Lot Expiration Information
Batch# 6402153, Exp Date: 11/30/2026
Batch# 6402297, 6402298, Exp Date: 01/31/2027
Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027
Batch# 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027
Batch# 6402434, Exp Date: 04/30/2027
Batch# 6402512, Exp Date: 05/2027
Batch# 6402574, 6402576, Exp Date: 06/30/2027.
Affected Packages Involved in this Recall
17271-701-02Product
17271-701-03Product
17271-701-05Product
17271-701-06Product
17271-701-07Product
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
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Batch or Lot Expiration Information
Batch# 6402428, Exp Date: 10/31/2026
Batch# 6402481, 6402482, Exp Date: 11/30/2026.
Affected Packages Involved in this Recall
17271-701-02Product
17271-701-03Product
17271-701-05Product
17271-701-06Product
17271-701-07Product
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
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
Batch or Lot Expiration Information
Batch# 6402290, 6402291, Exp Date: 01/31/2028
Batch# 6402411, Exp Date: 02/29/2028
Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028
Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028
Batch# 6402518, Exp Date: 06/30/2028.
Affected Packages Involved in this Recall
17271-701-02Product
17271-701-03Product
17271-701-05Product
17271-701-06Product
17271-701-07Product
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.
