Fresenius Kabi USA Recall of 0.9% Sodium Chloride Injection Due to Sterility Issues
Summary
Fresenius Kabi USA, LLC initiated a Class II drug recall for 0.9% Sodium Chloride Injection, USP (NDC 65219-282, 1,000 mL freeflex bags) distributed nationwide, to Alaska, and to Puerto Rico. The recall was triggered by lack of assurance of sterility affecting multiple batch numbers with expiration dates ranging from December 2026 through May 2028. The voluntary recall was initiated by the firm on March 11, 2026, and classified by FDA on April 3, 2026.
What changed
Fresenius Kabi USA, LLC issued a Class II recall for 0.9% Sodium Chloride Injection, USP (NDC 65219-282) in 1,000 mL single-dose freeflex bags. The recall covers batch numbers 23SU10001, 24AU10003 through 24AU10008, 24EU10001, 24EU10002, 24PU10002, 25BU10003, and 25EU10005, with expiration dates from December 2026 through May 2028. Distribution included US nationwide, Alaska, and Puerto Rico.
Healthcare providers, pharmacies, and distributors holding affected lots should quarantine the product and contact Fresenius Kabi for return instructions. The recall is ongoing, and no specific patient remediation steps or required actions are detailed in the recall notice beyond standard product disposition procedures.
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-0433-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medica...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, 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: 65219-282
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 282100 NDC 65219-282-10 Package of 10 0.9% (9 mg/mL) NDC 65219-282-01 1000 mL in a 1000 mL free flex ® bag Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made wit...
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