Drug FDA Class II Ongoing Contamination / non-sterility

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

CareFusion 213, LLC Published Jan 7, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact CareFusion 213, LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Lack of Assurance of Sterlity

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

CHLORAPREP SWABSTICK · 106,400 units

NDC: 54365-401, 54365-401-28, 54365-401-29

Code info: Lot #: 5086623, Exp. Date 03/31/2028

Affected areas

Nationwide

Timeline

Initiated

Dec 17, 2025
Published

Jan 7, 2026

Recall number: D-0243-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.