FDA Drugs recall ·
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0259-2025
- Date
- (initiated February 14, 2025)
- Company / brand
- CareFusion 213, LLC
1550 Northwestern Dr, El Paso, TX, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 205,440 applicators
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Why was it recalled?
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
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 #: 3200240, Exp 6/30/2026
Distribution
Nationwide and Canada
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-0259-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.