BD ChloraPrep Clear — Class I drug recall D-0624-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-07-01, distributed nationwide. Non-Sterility: Due to presence of Aspergillus penicillioides.
| Recall number | D-0624-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-05-28 |
| Classified | 2026-06-25 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 193,440 applicators |
| Reason classes | sterility |
| Pathogens | mold |
| NDC | 54365-0400, 54365-0400-31 |
| Lot numbers | 4032183 |
| Expiration dates | 2027-01-31 |
Product
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.
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-0624-2026. 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.