BD ChloraPrep Clear 1mL Applicators — Class I drug recall D-0259-2025
Ongoing recall by CareFusion 213, LLC, reported 2025-03-19, distributed nationwide. Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
| Recall number | D-0259-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2025-02-14 |
| Classified | 2025-03-07 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 205,440 applicators |
| Reason classes | sterility |
| Pathogens | mold |
| NDC | 54365-0400, 54365-0400-31 |
| Lot numbers | 3200240 |
| Model numbers | 930480 |
| Expiration dates | 2026-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0259-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.