Purprep Sponge
FDA Recall NDC 54365-014
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Purprep (NDC 54365-014). A significant event, classified as Class II, was initiated on Apr 22, 2026 by Carefusion 213 Llc. The reported reason for this action was: "Lack of assurance of Sterility: potential product contamination"
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 Sterility: potential product contamination
Apr 22, 2026
May 13, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98790
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Batch or Lot Expiration Information
Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Affected Packages Involved in this Recall
54365-014-42Product
54365-014-41Product
Class II Ongoing
Lack of assurance of Sterility: potential product contamination
Apr 22, 2026
May 13, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98790
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
CareFusion 213, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Batch or Lot Expiration Information
Lot# Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
Affected Packages Involved in this Recall
54365-014-42Product
54365-014-41Product
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.
