FDAFDA · Food and drugs·Recall number 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 carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Published May 13, 2026 · Recall initiated: April 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of Sterility: potential product contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PURPREP
- Manufacturer
- CareFusion 213, LLC
- Distributor
- Nationwide in the USA
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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