Fresenius Kabi USA Recalls 0.9% Sodium Chloride Injection Due to Lack of Sterility Assurance
Summary
Fresenius Kabi USA initiated a Class II voluntary recall of 0.9% Sodium Chloride Injection, USP (500 mL freeflex bags) due to lack of assurance of sterility. Affected lots include Batch# 24LU10013, 24LU10014 (Exp: 09/30/2027) and Batch# 24NU10001, 24NU10002 (Exp: 10/31/2027), distributed nationwide, to Alaska and Puerto Rico. The recall was initiated on 2026-03-11 and classified by FDA on 2026-04-03.
“Lack of Assurance of Sterility”
What changed
Fresenius Kabi USA initiated a voluntary Class II recall for 0.9% Sodium Chloride Injection, USP (500 mL freeflex bags) due to lack of assurance of sterility. The recall affects four batch numbers distributed nationwide and to Alaska and Puerto Rico. FDA classified the recall on April 3, 2026.
Healthcare facilities, pharmacies, and distributors should immediately identify quarantined stock of the affected lots and initiate return procedures through Fresenius Kabi. No specific patient adverse events are reported in the recall notice; however, compromised sterility in injectable solutions presents a risk of infection if administered.
What to do next
- Identify and quarantine affected lots: Batch# 24LU10013, 24LU10014, 24NU10001, 24NU10002
- Return affected product per firm's recall instructions
- Contact Fresenius Kabi USA for return authorization
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-0428-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
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...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
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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