Fresenius Kabi Sodium Chloride Recall, Sterility Concern
Summary
Fresenius Kabi USA, LLC initiates a voluntary Class II recall of 0.9% Sodium Chloride Injection, USP (Batch# 24EU10010, Exp 05/31/2027) distributed nationwide, Alaska, and Puerto Rico due to lack of assurance of sterility. The FDA classified this recall on April 3, 2026. Healthcare providers should verify their inventory for the affected lot and discontinue use if present.
What changed
Fresenius Kabi USA, LLC initiated a voluntary Class II drug recall affecting a single batch of 0.9% Sodium Chloride Injection, USP distributed across the US, Alaska, and Puerto Rico. The recall was triggered by concerns regarding lack of assurance of sterility. Batch# 24EU10010 with an expiration date of May 31, 2027 is affected. \n\nHealthcare providers and pharmacies should immediately verify their inventory against the affected lot number and quarantine any product identified. The recall is ongoing and was classified by the FDA on April 3, 2026. Patients who may have received this product should consult their healthcare provider if they have concerns.
What to do next
- Verify inventory for Batch# 24EU10010, 0.9% Sodium Chloride Injection, USP, Exp 05/31/2027
- Discontinue use and quarantine any affected product
- Contact Fresenius Kabi per the notification letter for return instructions
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-0434-2026 · 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, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distr...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Batch# 24EU10010, Exp Date: 05/31/2027.
Firm Notification Method
Letter
Distribution
US Nationwide , Alaska, and Puerto Rico.
Initiated
20260311
FDA Classified
20260403
Product Registration
Brand: SODIUM CHLORIDE
Manufacturer: Becton Dickinson and Company
Application: ANDA207310
NDC: 17271-701
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.
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 No. NDC No. Strength Fill Sizes Bag Size 1727170102 17271-701-02 0.9% (9 mg/mL) 50 mL 100 mL 1727170103 17271-701-03 0.9% (9 mg/mL) 100 mL 100 mL 1727170105 17271-701-05 0.9% (9 mg/mL) 250 mL 250 mL 1727170106 17271-701-06 0.9% (9 mg/mL) 500 mL 500 mL 1727170107 17271-701-...
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