December 2025 FDA Recall Chloraprep Swabstick by Carefusion 213, Llc
D-0243-2026 - Lack of Assurance of Sterlity
This Class II drug recall was voluntarily initiated by Carefusion 213, Llc on December 17, 2025 for the product Chloraprep Swabstick. The FDA reported the reason for recall as lack of assurance of sterlity. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0243-2026
Lack of Assurance of Sterlity
12-17-2025
01-07-2026
106,400 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
CareFusion 213, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 5086623, Exp. Date 03/31/2028
