BD ChloraPrep FREPP Clear — Class II drug recall D-0623-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-07-01, distributed nationwide. Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
| Recall number | D-0623-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-05-28 |
| Classified | 2026-06-25 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 54365-0400, 54365-0400-30 |
| Lot numbers | 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3171115, 3172853, 3177820, 3191056, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, 3222170, 3226846, 3228153, 3228293, 3229867, 3230424, 3234042, 3240990, 3243337, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, 3261058, 3263492, 3264573, 3268341 and 157 more |
| Expiration dates | 2026-05-31, 2026-06-30, 2026-07-31, 2026-08-31, 2026-09-30, 2026-10-31, 2026-11-30, 2026-12-31, 2027-01-31, 2027-02-28, 2027-03-31, 2027-04-30, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31, 2027-09-30, 2027-10-31 |
Product
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Reason for recall
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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-0623-2026. 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.