Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- DEXTROSE, FRESENIUS KABI USA, LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- DEXTROSE, FRESENIUS KABI USA, LLC
- Product type
- Intravenous (IV) Dextrose Solution
- Model numbers
- Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
- UPC codes
- 65219-456, 65219-464, 65219-458, 65219-460, 65219-462, 65219-456-05, 65219-456-60, 65219-464-05 +7 more
- Sizes
- 100 mL freeflex bag
- Sold at
- Multiple Retailers
- 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
This IV solution provides necessary fluids and glucose for patients unable to ingest food or fluids by mouth. It is used in hospitals and clinics.
Why This Is Dangerous
Lack of sterility can introduce microbes into the bloodstream, causing sepsis or other infections in patients.
Industry Context
This recall is not part of a broader industry pattern according to available data.
Real-World Impact
Hospitals may need to substitute with other sterile IV fluids and manage inventory to avoid treatment delays.
Practical Guidance
How to identify if yours is affected
- Check expiration date 02/28/2027
- Confirm product is in 100 mL freeflex bag
Where to find product info
NDC numbers are on the label. Batch numbers and expiration are printed on the bag and carton.
What timeline to expect
Refund or replacement guidance will be issued by Fresenius Kabi in the recall notification; timelines are not specified.
If the manufacturer is unresponsive
- Document all communication attempts
- Escalate to hospital risk management or the supplier’s recall contact
- File a formal complaint with FDA if needed
How to prevent similar issues
- Verify sterility recalls before administration
- Maintain updated inventory of sterile IV solutions
- Establish clear recall contact protocols with suppliers
Documentation advice
Keep recall letter, batch records, and correspondence; store as evidence for audits or claims
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Product Details
Product: 5% Dextrose Injection, USP, 5 g per 100 mL (50 mg per mL), 100 mL freeflex bag. Company: Fresenius Kabi USA, LLC. NDC: 65219-464-05 (Unit of Use), 65219-464-50 (Unit of Sale). Batches: 6402399, 6402400, 6402401. Expiration: 02/28/2027. Sold in the US including Alaska and Puerto Rico. Recall date: 2026-03-11. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 5% Dextrose Injection, USP in freeflex bag
- Distribution: Nationwide US, including Alaska and Puerto Rico
- Recall date 2026-03-11; status ACTIVE
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Safety Guide
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