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Class I · Most seriousActive recall

Chloraprep One-Step

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # 4073005, Exp 03/31/2027
Where it was soldNationwide inthe USA, as well as other foreign distribution.
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

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

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 labelBD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Recalling firmCareFusion 213, LLC
DistributionNationwide inthe USA, as well as other foreign distribution.
Quantity178,000 applicators
Recall initiated2026-05-28
Report date2026-07-01
Recall completed—
Recall numberD-0625-2026
ClassificationClass I
FDA statusOngoing
Origin on fileEl Paso TX United States

Related

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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.