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Class II · ModerateActive recall

Purprep

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of assurance of Sterility: potential product contamination

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCareFusion 213 LLC
Brand namePURPREP
Generic namePOVIDONE IODINE AND ISOPROPYL ALCOHOL
Active ingredient(s)ISOPROPYL ALCOHOL, POVIDONE-IODINE
Distributed by / forCareFusion 213, LLC
NDC54365-014-41
Show the full FDA record
Full product labelBD 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
Recalling firmCareFusion 213, LLC
DistributionNationwide in the USA
Recall initiated2026-04-22
Report date2026-05-13
Recall completed—
Recall numberD-0518-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEl Paso TX United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.