PURPREP
Recalling Firm / Manufacturer: CareFusion 213, LLC
(El Paso, TX, United States)
FDA Recall Number: D-0517-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
PURPREP
Generic Name
POVIDONE IODINE AND ISOPROPYL ALCOHOL
Active Substance(s)
Isopropyl Alcohol, Povidone-iodine
Administration Route
Topical
National Drug Code (NDC)
54365-014
Total Quantity Recalled
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Lack of assurance of Sterility: potential product contamination
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
May 13, 2026
Firm Initiation Date
April 22, 2026
FDA Classification Date
May 05, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
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.
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0517-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508603UTCC