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Class II · ModerateActive recall

Chloraprep One-Step

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

Does this affect you?
Check your lot numberLot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
Where it was soldDistributed Nationwide 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: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

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 nameCHLORAPREP ONE-STEP
Generic nameCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Active ingredient(s)CHLORHEXIDINE GLUCONATE, ISOPROPYL ALCOHOL
Distributed by / forCareFusion 213, LLC
NDC54365-400-30
Show the full FDA record
Full product labelChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Recalling firmCareFusion 213, LLC
DistributionDistributed Nationwide in the USA
Quantity10,500 units
Recall initiated2026-06-11
Report date2026-07-08
Recall completed—
Recall numberD-0646-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEl Paso TX United States

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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.