Agency classClass IIOur severity:Severe FDA (Drugs)·D-0517-2026·Announced 2026-05-13

PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance

CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution 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: The FDA classified this as Class II with a sterile pharmaceutical product lacking assurance of sterility—a critical manufacturing defect in a parenteral/topical antiseptic that could result in serious infection if contaminated product is used in clinical settings, meeting the Severe (Score 4) criterion.

Plain-English summary

CareFusion 213, LLC is recalling BD PurPrep, a sterile topical solution containing 8.3% povidone-iodine (0.83% available iodine) and 72.5% isopropyl alcohol. The recall is due to lack of assurance of sterility and potential product contamination. Affected cartons contain 25 applicators of 26mL each.

The recall affects specific lot numbers with expiration dates in August, September, and October 2026. Affected lot numbers include 4258309, 4260329, 4256875 (08-31-2026), 4296453, 4317319, 4290654 (09-30-2026), and 4322449, 4323861, 4318679 (10-31-2026). The product was distributed nationwide in the United States.

Consumers and healthcare facilities using affected cartons should stop use immediately. Contact CareFusion 213, LLC or consult with a healthcare provider regarding proper disposal and product replacement. The product is manufactured by CareFusion 213, LLC in El Paso, Texas (NDC 54365-014-42).

The recalled product

Product: PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
Brand: PURPREP
Manufacturer: CareFusion 213, LLC
Category: Drug — Topical Antiseptic / Surgical Prep
Hazard: sterility-failure
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 (13)

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.

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
BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall
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 Sterile Solution Lacks Assurance of Sterility
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

Same hazard · sterility failure