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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.