HIGHFDA DRUG

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...

Lack of assurance of Sterility: potential product contamination

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
April 22, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 22, 2026
Hazard Level
HIGH
Brands
PURPREP, CareFusion 213 LLC
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PURPREP, CareFusion 213 LLC
Model numbers
Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
UPC codes
54365-014, 54365-014-42, 54365-014-41
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 22, 2026

  2. Reported by FDA DRUG

    May 13, 2026

  3. RecallRadar source check

    May 20, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Lack of assurance of Sterility: potential product contamination

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CareFusion 213, LLC or your healthcare provider for guidance. Notification method: Letter

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Full 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. Generic: POVIDONE IODINE AND ISOPROPYL ALCOHOL; Brand: PURPREP. Reason: Lack of assurance of Sterility: potential product contamination. Classification: Class II. Distribution: Nationwide in the USA

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lots# 4263873
Exp. Date 08-31-2026
4320590
Exp. Date 09-30-2026
4320591
+1 more
UPC Codes
54365-014
54365-014-42
54365-014-41
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE