UnratedDrug recall · FDA · Published December 17, 2025
CareFusion BD ChloraPrep Triple Swabsticks Recall: Risk of Contaminated Swabs
CareFusion recalls BD ChloraPrep Triple Swabsticks due to lack of assurance of sterility. These swabs may be contaminated and could cause infection if used during medical procedures.
“CareFusion BD ChloraPrep Triple Swabsticks Recall: Risk of Contaminated Swabs.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31611-carefusion-bd-chloraprep-triple-swabsticks-recall-risk-of-contaminated-swabs. Based on FDA recall #D-0243-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0243-2026%22&limit=1).
The FDA announced on Dec. 17, 2025, that CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks due to a lack of assurance of sterility. The voluntary Class II recall affects 106,400 units distributed nationwide.
How to tell if you have it
Brand: CareFusion
Product: BD ChloraPrep Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator
NDC: 54365-401-29
Lot #: 5086623
Exp. Date: 03/31/2028
The hazard
The recall is due to a lack of assurance of sterility for the BD ChloraPrep Triple Swabsticks applicators. According to FDA's FAERS database, there are 20 adverse-event reports naming this product, with 19 marked serious and 11 listing a death.
Context
GovInfoNow's records show CareFusion 213, LLC has 16 other recalls on record since 2011-11-08. Other recent recalls of similar products include BD ChloraPrep Clear 60x1mL (2026-07-09), CareFusion ChloraPrep FREPP 500x1.5mL (2026-06-11), and BD ChloraPrep Clear 1mL Applicator (2026-05-28). Other recent recalls of similar products include Asclemed Lidocaine HCl Injection (2026-06-08), Chiesi CLEVIPREX 50mg/100mL injectable vials (2026-07-06), and Zep Alcohol Sanitizer Spray (2026-05-22).
How to tell if you have this one
Look for the product name 'BD ChloraPrep Triple Swabsticks' with NDC 54365-401-29. The lot number is 5086623 and expiration date is 03/31/2028.
Brand
CareFusion
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 54365-401-29 and lot number 5086623 on the swab package.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0243-2026 (December 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0243-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.