BD PurPrep — Class II drug recall D-0517-2026
Ongoing recall by CareFusion 213, LLC, reported 2026-05-13, distributed nationwide. Lack of assurance of Sterility: potential product contamination
| Recall number | D-0517-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2026-04-22 |
| Classified | 2026-05-05 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 54365-0014, 54365-0014-41, 54365-0014-42 |
| Lot numbers | 10-31, 4256875, 4258309, 4260329, 4290654, 4296453, 4317319, 4318679, 4322449, 4323861 |
| Expiration dates | 2026-08-31, 2026-09-30 |
Product
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Reason for recall
Lack of assurance of Sterility: potential product contamination
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-0517-2026. 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.