Quick Facts at a Glance
- Recall Date
- May 28, 2026
- Hazard Level
- HIGH
- Brands
- CHLORAPREP ONE-STEP, 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
- CHLORAPREP ONE-STEP, CareFusion 213, LLC
- Model numbers
- Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919 +12 more
- UPC codes
- 54365-400, 54365-400-30
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 28, 2026
Reported by FDA DRUG
July 1, 2026
RecallRadar source check
July 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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 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.. Generic: CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL; Brand: CHLORAPREP ONE-STEP. Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.. Classification: Class II. Quantity: N/A. Distribution: Nationwide inthe USA, as well as other foreign distribution.
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Safety Guide
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