Recall: D-0518-2026

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, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41

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.