Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM CHLORIDE, Fresenius Kabi USA, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SODIUM CHLORIDE, Fresenius Kabi USA, LLC
- Model numbers
- Batch# 23DU10004, Exp Date: 04/30/2026, Batch# 23HU10006, Exp Date: 06/30/2026.
- UPC codes
- 65219-328, 65219-432, 65219-432-20, 65219-432-85, 65219-328-10, 65219-328-50
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 11, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.. Generic: SODIUM CHLORIDE; Brand: SODIUM CHLORIDE. Reason: Lack of Assurance of Sterility. Classification: Class II. Distribution: US Nationwide , Alaska, and Puerto Rico.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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