Carefusion 213, Llc: Bd Chloraprep Clear, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol (ipa)

Recall Summary BD ChloraPrep Clear, a skin antiseptic solution used before medical procedures, is being recalled nationwide because wrinkles in the paper lid may compromise the sterile seal on the 1 mL applicator bottles. The manufacturer, CareFusion 213, LLC, cannot guarantee the product remains sterile due to this packaging defect. This recall affects all 50 U.S. states plus Washington, D.C., as well as some international locations.

Recalling firm
CareFusion 213, LLC
Product
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
Reason
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-05-28
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide inthe USA, as well as other foreign distribution.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/bd55971b-65f5-41ac-bf64-35d16cdcb711