Official recall notice
FDA DrugClass INotable
BD ChloraPrep FREPP Clear Recall (Jul 2026) – CareFusion 213
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.
- Recall date
- 2026-07-01
- Brand
- CareFusion 213, LLC
- Category
- Drug
- FDA class
- Class I
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Lot # 4073005, Exp 03/31/2027