# FDA recall D-0259-2025

> **CareFusion 213, LLC** · Class I · drug recall initiated 2025-02-14.

## 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.

## Reason for recall

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-0259-2025
- **Recalling firm:** CareFusion 213, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-14
- **Report date:** 2025-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Paso, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0259-2025

## Citation

> AI Analytics. FDA recall D-0259-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0259-2025. Source: US FDA. Licensed CC0.

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