BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5%… recall
FDA recall D-0518-2026 · initiated Apr 22, 2026
CareFusion 213, LLC recalled BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… in Apr 2026 — an FDA Class II recall (D-0518-2026) because Lack of assurance of Sterility: potential product contamination.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of Sterility: potential product contamination
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- CareFusion 213, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 22, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… recalled?
- CareFusion 213, LLC recalled BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… in Apr 2026 — an FDA Class II recall (D-0518-2026) because Lack of assurance of Sterility: potential product contamination. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… recalled?
- Per the FDA enforcement record, the reason for recall D-0518-2026 was: Lack of assurance of Sterility: potential product contamination
- Is a recalled BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc… are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0518-2026.