CareFusion 213, LLC: Drug Recall

Recall #D-0243-2026 · 12/17/2025

Class II: Risk

Recall Details

Recall Number: D-0243-2026
Classification: Class II
Product Type: Drug
Recalling Firm: CareFusion 213, LLC
Status: Ongoing
Date Initiated: 12/17/2025
Location: El Paso, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 106,400 units

Reason for Recall

Lack of Assurance of Sterlity

Product Description

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

Distribution Pattern

Nationwide within the United States

Other Recalls by CareFusion 213, LLC

Class II: Risk 05/15/2025

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class I: Dangerous 02/14/2025

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II: Risk 08/25/2023

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
Class I: Dangerous 04/20/2021

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Class I: Dangerous 03/19/2021

Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

View all recalls by CareFusion 213, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.