BD ChloraPrep Clear — Class II drug recall D-0441-2025
Ongoing recall by CareFusion 213, LLC, reported 2025-05-28, distributed nationwide. Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicat
| Recall number | D-0441-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2025-05-15 |
| Classified | 2025-05-20 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 385,200 applicators |
| Reason classes | sterility, packaging |
| NDC | 54365-0400, 54365-0400-31 |
| Lot numbers | 3350974, 3354127 |
| Model numbers | 930480 |
| Expiration dates | 2026-12-31 |
Product
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Reason for recall
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
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-0441-2025. 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.