FDA recall D-0517-2026

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-04-22

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2026