D-0624-2026 Class I Ongoing
FDA drug recall D-0624-2026 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. The recall status is ongoing. Affected quantity: 193,440 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
- 193,440 applicators
Product Description
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
Reason for Recall
Non-Sterility: Due to presence of Aspergillus penicillioides.
Distribution Pattern
Nationwide inthe USA, as well as other foreign distribution.
Code Information
Lot # 4032183, Exp 01/31/2027