Quick Facts at a Glance
- Recall Date
- December 17, 2025
- Hazard Level
- HIGH
- Brands
- ChloraPrep, CareFusion
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- ChloraPrep, CareFusion
- Product type
- ChloraPrep Swabsticks
- Model numbers
- Lot #: 5086623, Exp. Date 03/31/2028
- UPC codes
- 54365-401, 54365-401-28, 54365-401-29
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 17, 2025
Reported by FDA DRUG
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterlity
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact CareFusion 213, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
ChloraPrep Swabsticks are antiseptic applicators used to prepare skin for medical procedures by reducing bacteria. They are commonly used in healthcare settings and by individuals for minor procedures.
Why This Is Dangerous
The lack of assurance of sterility means the swabsticks may not effectively eliminate bacteria, increasing the risk of infection during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks if they have used the affected swabsticks. The recall requires immediate action to prevent potential infections.
Practical Guidance
How to identify if yours is affected
- Check the lot number on the packaging: 5086623.
- Verify the expiration date: March 31, 2028.
- If both match, the product is recalled.
Where to find product info
Look for the lot number and expiration date printed on the swabstick packaging.
What timeline to expect
Expect a refund or replacement processing time of about 4-6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with CareFusion.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Always check for recall information before using medical products.
- Look for products with guaranteed sterility certifications.
Documentation advice
Keep all receipts, correspondence with CareFusion, and any medical records related to the use of the product.
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Product Details
The recalled product is BD ChloraPrep Triple Swabsticks, containing Chlorhexidine gluconate (2% w/v) and Isopropyl alcohol (70% v/v). The lot number is 5086623 with an expiration date of March 31, 2028. The swabsticks were distributed nationwide in the United States.
Key Facts
- Risk of infection due to sterility issues
- Stop using product immediately
- Contact CareFusion for more information
- Distributed nationwide in the U.S.
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Safety Guide
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