D-0625-2026 Class I Ongoing
FDA drug recall D-0625-2026 was initiated by CareFusion 213, LLC on May 28, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 178,000 applicators.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- May 28, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178,000 applicators
Product 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.
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.
Distribution Pattern
Nationwide inthe USA, as well as other foreign distribution.
Code Information
Lot # 4073005, Exp 03/31/2027