Recall: D-0517-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-22Initiated

OngoingStatus

CareFusion 213, LLCFirm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.