CareFusion 213, LLC recalls BD ChloraPrep FREPP Clear
- Recalling company
- CareFusion 213, LLC
- Product
- 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.
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 28, 2026
- Reported
- Jul 1, 2026
- Distribution
- Nationwide inthe USA, as well as other foreign distribution.
- Status
- Ongoing
- Quantity
- 178,000 applicators
- Lot / codes
- Lot # 4073005, Exp 03/31/2027
- Company location
- El Paso, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0625-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0625-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.