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
- 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
- DEXTROSE, FRESENIUS KABI USA, LLC
- Product type
- Intravenous (IV) Dextrose Solution
- Model numbers
- Batch# 6402165, Exp Date: 05/30/2028.
- UPC codes
- 65219-456, 65219-464, 65219-458, 65219-460, 65219-462, 65219-456-05, 65219-456-60, 65219-464-05 +7 more
- Sizes
- 250 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
5% Dextrose Injection is used to provide calories and fluid therapy in clinical settings. In 250 mL FreeFlex bags, it is designed for IV administration.
Why This Is Dangerous
Lack of sterility assurance raises risk of infection or contamination during IV treatment, which can be life-threatening in vulnerable patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must audit IV fluid inventories and isolate affected lots to prevent use; patients may require alternative therapies and monitoring.
Practical Guidance
How to identify if yours is affected
- Check NDCs 65219-458-05 (Unit of Use) and 65219-458-30 (Unit of Sale).
- Verify Batch 6402165 and Exp 05/30/2028 on the unit.
- Inspect FreeFlex bag label for 250 mL size.
Where to find product info
FDA recall page and Fresenius Kabi communications; unit labels and lot records in pharmacy
What timeline to expect
Replacement or refund processing timelines are facility dependent; typical ranges are 2-8 weeks depending on hospital systems and supplier processes
If the manufacturer is unresponsive
- Escalate to the hospital risk management or pharmaceutical supply chain manager
- File a formal incident report with the hospital peer-review committee
How to prevent similar issues
- Implement strict receiving controls for IV solutions
- Verify sterility confirmations from suppliers
- Maintain segregated hold areas for suspect lots
- Educate clinical staff on recall protocols
Documentation advice
Document batch number, expiration date, lot, and efforts to contact supplier; retain correspondence and inventory reports
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Product Details
Brand: DEXTROSE; Brand owner: Fresenius Kabi USA, LLC; Product: 5% Dextrose Injection, USP 12.5 g/250 mL in 250 mL FreeFlex bag; Unit of Use NDC: 65219-458-05; Unit of Sale NDC: 65219-458-30; Batch: 6402165; Expiration: 05/30/2028; Distribution: US Nationwide, Alaska, Puerto Rico; Recall date: 2026-03-11; Status: ACTIVE.
Reported Incidents
No incident counts are provided in the source material.
Key Facts
- 5% Dextrose Injection, USP 12.5 g/250 mL
- Unit of Use NDC 65219-458-05
- Unit of Sale NDC 65219-458-30
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Safety Guide
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