CLASS II ONGOING Drug recall · Reported 26 Oct 2022 · FDA Enforcement Report

0.9% Sodium Chloride Injection, USP, Each contains recalled

Fresenius Medical Care Holdings is recalling 0.9% Sodium Chloride Injection, USP, Each contains: Sodium Chloride, USP - 900 mg, Water, distributed nationwide in the US. The recall was initiated on 11 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 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

NDC49230-300

Quantity recalled16,006 cases of twelve bags each

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0015-2023
FDA event ID: 90997
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Brand: Sodium Chloride
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Classification: Class II
Status: Ongoing
Recall initiated: 11 Oct 2022
FDA classified: 20 Oct 2022
Reported: 26 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

11 Oct 2022	Recall initiated by company
20 Oct 2022	Classified by FDA	+9 days
26 Oct 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Which lots are affected?

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

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Sodium Chloride recalls

All 132

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
13 May 2026Drug	CLASS I	Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation	B Braun Medical	Sterility	Nationwide
22 Apr 2026Drug	CLASS II	0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride	Huons	Sterility	Nationwide