BD ChloraPrep Clear — Class II drug recall D-0690-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-07-22, distributed nationwide. Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of th
| Recall number | D-0690-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-07-09 |
| Classified | 2026-07-15 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 43,066,599 units |
| Reason classes | sterility, packaging |
| NDC | 54365-0400, 54365-0400-31 |
| Lot numbers | 4062535, 4065201, 4066446, 4141090, 4180288, 4180291, 4197695, 4197697, 4219454, 4221945, 4221966, 4222853, 4224361, 4228482, 4248656, 4248961, 4249026, 4249818, 4250729, 5124984, 5126398, 5127231, 5129058, 5129488, 5130576, 5142947, 5147432, 5150160, 5154671, 5154673, 5155824, 5156442, 5157968, 5158031, 5176326, 5181074, 5181676, 5182660, 5188102, 5188103 and 36 more |
| Expiration dates | 2027-02-28, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31, 2028-04-30, 2028-05-31, 2028-06-30, 2028-07-31, 2028-08-31, 2028-09-30, 2028-10-31, 2028-12-31, 2029-01-31, 2029-02-28, 2029-03-31, 2029-04-30 |
Product
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Reason for recall
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete 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-0690-2026. 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.