Quick Facts at a Glance
- Recall Date
- June 11, 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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Lot: 4298581, expires: 09/30/2026.
- UPC codes
- 54365-014, 54365-014-42, 54365-014-41
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 11, 2026
Reported by FDA DRUG
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
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), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.. Generic: POVIDONE IODINE AND ISOPROPYL ALCOHOL; Brand: PURPREP. Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel. Classification: Class II. Quantity: N/A. Distribution: Distributed Nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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