FDA Drug recall D-0517-2026
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per ca…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per ca… by Carefusion 213, citing lack of assurance of Sterility: potential product contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0517-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-22 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | US |
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
Lack of assurance of Sterility: potential product contamination
Identifiers
| ndc | 54365-014-42 |
|---|---|
| ndc | 54365-014-41 |
| code_info | Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0517-2026%22
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