Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM CHLORIDE, Fresenius Kabi USA, LLC
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Product type
- Sterile Injectable Solution
- Model numbers
- Batch# 6402372, 6402374, Exp Date: 08/31/2026, Batch# 6402437, Exp Date: 10/31/2026.
- UPC codes
- 65219-466, 65219-468, 65219-470, 65219-472, 65219-474, 65219-466-05, 65219-466-60, 65219-468-05 +7 more
- Sizes
- 50 mL
- Sold at
- Unknown
- 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
About This Product
0.9% Sodium Chloride Injection is an intravenous sterile saline solution used in medical settings for fluid and electrolyte management.
Why This Is Dangerous
Lack of sterility assurance means there could be contamination, posing infection risk if administered intravenously.
Industry Context
This recall is not necessarily part of a broader industry pattern, based on available data.
Real-World Impact
For patients, this recall could interrupt IV therapy and require replacement products, potentially delaying treatment.
Practical Guidance
How to identify if yours is affected
- Identify NDC 65219-466-05 (Unit of Use) or NDC 65219-466-60 (Unit of Sale).
- Verify expiration dates 08/31/2026 or 10/31/2026.
Where to find product info
Product packaging and labeling will list NDC numbers, batch numbers, and expiration dates.
What timeline to expect
Refunds or replacements are issued per Fresenius Kabi guidance; processing could take several weeks.
If the manufacturer is unresponsive
- Contact healthcare facility regulatory liaison.
- File a report with the FDA if needed.
How to prevent similar issues
- Verify sterility and lot integrity on all IV fluids before administration.
- Inspect packaging for damage prior to use.
Documentation advice
Keep the recall notice, batch records, and any correspondence with Fresenius Kabi and healthcare facilities.
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Product Details
Brand: Fresenius Kabi USA, LLC. Product: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) 50 mL. Route: Rx only. Unit of Use NDC: 65219-466-05. Unit of Sale NDC: 65219-466-60. Batch numbers: 6402372, 6402374, 6402437. Expiration dates: 08/31/2026 and 10/31/2026. Sold nationwide in the US, including Alaska and Puerto Rico.
Reported Incidents
No specific injuries or incidents are described in the provided data.
Key Facts
- Unit of Use NDC: 65219-466-05
- Unit of Sale NDC: 65219-466-60
- Status: ACTIVE recall as of 2026-04-15
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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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