BD PurPrep recalled over sterility concerns

Recall date

April 22, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26m…

Recall number

D-0517-2026

FDA classification

Class II

Brand / firm

CareFusion 213, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of assurance of Sterility: potential product contamination

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.