FDAFDA recall D-0625-2026 · Jul 1, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear recall
Recall found
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 for recall
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
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 4073005, Exp 03/31/2027
- Quantity
- 178,000 applicators
- Distribution
- Nationwide inthe USA, as well as other foreign distribution.
- Recalling firm
- CareFusion 213, LLC, El Paso, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-28
Source: openFDA enforcement record D-0625-2026 · search recall number D-0625-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.