Agency classClass IIOur severity:Severe FDA (Drugs)·D-0518-2026·Announced 2026-05-13

BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall

CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a sterile drug product with a sterility defect, which poses a potential for serious adverse health consequences. Under the rubric, FDA Class II recalls with risk of serious harm qualify as Severe (score 4).

Plain-English summary

CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% w/w with isopropyl alcohol 72.5% w/w sterile solution), 0.36 fl. oz. (10.5 mL) x 25 applicators per box, NDC 54365-014-41. The recall is due to lack of assurance of sterility and potential product contamination.

The affected lots are: - Lot 4263873, expiration date 08-31-2026 - Lot 4320590, expiration date 09-30-2026 - Lot 4320591, expiration date 10-31-2026

The product has been distributed nationwide in the USA. Consumers should stop using the product and contact their healthcare provider if they have any questions or concerns.

The recalled product

Product: PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
Brand: PURPREP
Manufacturer: CareFusion 213, LLC
Category: Drug — Topical Antiseptic / Sterilization Prep
Hazard: lack-of-sterility
product-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Lots# 4263873
Exp. Date 08-31-2026
4320590
Exp. Date 09-30-2026
4320591
Exp. Date 10-31-2026.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · PURPREP

Severe
PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
Severe
PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-13

Same manufacturer · CareFusion 213, LLC

See all →

Severe
ChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
Severe
ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
Severe
ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08

Same hazard · lack of sterility