Fresenius Kabi USA Sodium Chloride Injection Recall D-0427-2026
Summary
FDA classified a Class II recall by Fresenius Kabi USA, LLC for 0.9% Sodium Chloride Injection, USP due to lack of assurance of sterility. The recall affects 16 lot numbers spanning expiration dates from December 2026 through May 2028, distributed nationwide, in Alaska, and in Puerto Rico.
What changed
FDA classified a Class II drug recall initiated by Fresenius Kabi USA, LLC for its 0.9% Sodium Chloride Injection, USP (250 mL freeflex bags) due to lack of assurance of sterility. The recall covers 16 batch numbers distributed nationwide and US territories. Affected parties including healthcare providers, pharmacies, and hospitals should identify and quarantine affected lots and contact Fresenius Kabi for return instructions.
Healthcare facilities that have distributed or administered this product should verify their inventory against the affected lot numbers and implement recall procedures. While Class II recalls indicate temporary or medically reversible health consequences are possible, the sterility concern warrants immediate identification of affected stock. The recalling firm initiated this action voluntarily and has notified consignees via letter.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Fresenius Kabi USA, LLC
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0427-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
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...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
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.
Firm Notification Method
Letter
Distribution
US Nationwide , Alaska, and Puerto Rico.
Initiated
20260311
FDA Classified
20260403
Product Registration
Brand: SODIUM CHLORIDE
Manufacturer: Fresenius Kabi USA, LLC
Application: ANDA207310
NDC: 65219-466, 65219-468, 65219-470
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
INDICATIONS AND USAGE Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).
Contraindications
CONTRAINDICATIONS None known.
Warnings
WARNINGS Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proportiona...
Adverse Reactions
ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVER...
Drug Interactions
DRUG INTERACTIONS Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not...
How Supplied
HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 416660 NDC 65219-466-60 Package of 60 0.9% (9 mg/mL) NDC 65219-466-05 50 mL in a 100 mL free flex ® bag 416650 NDC 65219-468-50 Package of 50 0.9% (9 mg/mL) NDC 65219-468-05 100 mL in a 100 mL free flex ® bag 416630 NDC 65219-470-30 Package ...
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