BD ChloraPrep Clear — Class II drug recall D-0645-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-07-08, distributed nationwide. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing
| Recall number | D-0645-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-06-29 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 146,600 units |
| Reason classes | sterility |
| NDC | 54365-0400, 54365-0400-32 |
| Lot numbers | 3199359, 3200136, 3212372, 3214024, 3237018, 3243267, 3264290, 3293904, 3313291, 3333265, 3334121, 4030693, 4031672, 4033380, 4058103, 4061583, 4065931, 4068589, 4081770, 4093245, 4094302, 4145548, 4146564, 4154588, 4166005, 4191049, 4213945, 4214794, 4215736, 4218807, 4241055, 4249036, 4254217, 4262802, 4270628, 4275877, 4276225, 4276231, 4277387, 4304554 and 53 more |
| Model numbers | 930400NS, 930500NSB |
| Expiration dates | 2026-06-30, 2026-07-31, 2026-08-31, 2026-10-31, 2026-11-30, 2027-01-31, 2027-02-28, 2027-03-31, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31, 2027-09-30, 2027-10-31, 2027-11-30, 2027-12-31, 2028-01-31, 2028-02-29, 2028-03-31, 2028-04-30, 2028-05-31, 2028-06-30, 2028-07-31, 2028-08-31, 2028-10-31 and 4 more |
Product
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Reason for recall
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
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-0645-2026. 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.