Chloraprep Swabstick Solution
FDA Recall NDC 54365-401
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Chloraprep Swabstick (NDC 54365-401). A significant event, classified as Class II, was initiated on Dec 17, 2025 by Carefusion 213 Llc. The reported reason for this action was: "Lack of Assurance of Sterlity"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterlity
Dec 17, 2025
Jan 07, 2026
106,400 units
Recall Profile & Regulatory Data
Event ID
98142
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
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
Batch or Lot Expiration Information
Lot# : 5086623, Exp. Date 03/31/2028
Affected Packages Involved in this Recall
54365-401-28Product
54365-401-29Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
