Sodium Chloride Injection
FDA Recall NDC 49230-300

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 49230-300). A significant event, classified as Class II, was initiated on May 27, 2025 by Fresenius Medical Care Renal Therapies Group, 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-0490-2025ONGOINGD-0777-2023TERMINATEDD-0075-2023ONGOINGD-0015-2023ONGOING

May 2025 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0490-2025
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
May 27, 2025
Reported
Jul 02, 2025
Quantity
3,651,468 containers

Recall Profile & Regulatory Data

Event ID
96877
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Batch or Lot Expiration Information
Lot# 24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014, 24SU06015, 24SU06016, 24SU06017, 24SU06018, 24SU06019, 24SU06020, 24SU06021, 24SU06022, 24SU06023, 24SU06024, 24SU06025,24SU06026, 24SU06028,24SU06029, 24SU06030, 24SU06031, 24SU06032, 24SU06033 24SU06034, 24SU06035, 24SU06036, 24SU06037, 24SU06038, 24SU06039, 24SU06040, 24SU06041, 24SU06042, 24SU06043, 24SU06044, 24SU06045, 24SU06046, 24SU06047, 24SU06048, 24SU06049, 24SU06050, 24SU06051, 24SU06052, 24SU06053, 24SU06054, 24SU06055, 24SU06056, & 24SU06057, Exp Date 12/31/25 25AU06001, 25AU06002, 25AU06003. 25AU06004, 25AU06005, 25AU06006, 25AU06007, 25AU06008, 25AU06009, 25AU06010, 25AU06011, 25AU06013, 25AU06017, 25AU06020 25AU06021, 25AU06022, 25AU06027, 25AU06028, 25AU06029, 25AU06030, 25AU06031 25AU06032, 25AU06034, 25AU06035, 25AU06036, 25AU06037, 25AU06038, 25AU06039 25AU06040, 25AU06041, 25AU06042, 25AU06043, 25AU06044, 25AU06045, 25AU06046 25AU06047, 25AU06048, 25AU06049, 25AU06050, 25AU06051, 25AU06052, 25AU06053 & 25AU06056, Exp Date 1/31/26 25BU06001, 25BU06003, 25BU06004, 25BU06005, 25BU06006, 25BU06007, 25BU06008 25BU06009, 25BU06010, 25BU06011, 25BU06018, 25BU06020, 25BU06023, 25BU06024 25BU06026, 25BU06027, 25BU06028, 25BU06030, 25BU06031, 25BU06032, 25BU06033 25BU06034, 25BU06035, 25BU06036, 25BU06037, 25BU06038, 25BU06039, 25BU06040 25BU06041, 25BU06042, 25BU06043, 25BU06044, 25BU06045, 25BU06046 25BU06047, 25BU06049, 25BU06050, 25BU06051, 25BU06053 & 25BU06054, Exp Date 02/28/26 25CU06002, 25CU06003, 25CU06004, 25CU06005, 25CU06006, 25CU06007, 25CU06008 25CU06012, 25CU06013, 25CU06015, 25CU06016, 25CU06020, 25CU06021, 25CU06022 25CU06023, 25CU06024, 25CU06026, 25CU06028, 25CU06030, 25CU06032, 25CU06035 25CU06039, Exp Date 03/31/2026
Affected Packages Involved in this Recall
49230-300-10Product

May 2023 Class II Recall: Lack of assurance of sterility

Recall Number
D-0777-2023
Class II Terminated
Reason for Recall
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Initiated
May 23, 2023
Reported
Jun 07, 2023
Quantity
53,424 bags

Recall Profile & Regulatory Data

Event ID
92403
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 32 clinics in SC, NC and VA.
Termination Date
May 23, 2024
Product Description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Batch or Lot Expiration Information
Lot# 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Affected Packages Involved in this Recall
49230-300-10Product

November 2022 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0075-2023
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Initiated
Nov 22, 2022
Reported
Dec 14, 2022
Quantity
4,097 cases/12 bags per case

Recall Profile & Regulatory Data

Event ID
91226
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed Nationwide in the USA.
Product Description
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Batch or Lot Expiration Information
Lot# 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023
Affected Packages Involved in this Recall
49230-300-10Product

October 2022 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0015-2023
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Initiated
Oct 11, 2022
Reported
Oct 26, 2022
Quantity
16,006 cases of twelve bags each

Recall Profile & Regulatory Data

Event ID
90997
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Batch or Lot Expiration Information
Lot# 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023
Affected Packages Involved in this Recall
49230-300-10Product

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.