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.
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: 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
- 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.