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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

BD ChloraPrep Triple Swabsticks Recalled for Lack of Sterility Assurance

Agency Publication Date: December 30, 2025
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Summary

CareFusion 213, LLC is recalling 106,400 units of BD ChloraPrep Triple Swabsticks (chlorhexidine gluconate and isopropyl alcohol) because they may lack assurance of sterility. These 5.25 mL applicators are used for skin preparation before medical procedures. Using a non-sterile product on skin before a procedure can lead to serious infections, particularly in clinical settings.

Risk

A lack of sterility assurance means the product may contain microorganisms that can cause serious or life-threatening infections if used on patients during surgical or medical procedures.

What You Should Do

  1. Stop using the recalled BD ChloraPrep Triple Swabsticks immediately.
  2. Identify the affected product by checking the packaging for lot number 5086623 with an expiration date of 03/31/2028 and NDC 54365-401-29.
  3. Contact the manufacturer, CareFusion 213, LLC, or your distributor to arrange for the return of any unused product from this lot.
  4. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: BD ChloraPrep Triple Swabsticks (5.25 mL Applicator)
Variants: Chlorhexidine gluconate (CHG) 2% w/v, Isopropyl alcohol (IPA) 70% v/v
Lot Numbers:
5086623 (Exp 03/31/2028)
NDC:
54365-401-29

Recall #: D-0243-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98142
Status: Active
Manufacturer: CareFusion 213, LLC
Sold By: Wholesalers; Hospitals; Medical distributors
Manufactured In: United States
Units Affected: 106,400 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.