FDA Drugs recall ·
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70%… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0625-2026
- Date
- (initiated May 28, 2026)
- Company / brand
- CareFusion 213, LLC
1550 Northwestern Dr, El Paso, TX, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 178,000 applicators
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 4073005, Exp 03/31/2027
Distribution
Nationwide inthe USA, as well as other foreign distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0625-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.