PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.
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 a Class II drug recall. The hazard involves loss of sterility assurance on a topical antiseptic intended for medical procedures, which poses a risk of infection or adverse health consequences if the product is used as intended. Class II recalls with potential for serious health impact meet the Severe criterion.
Plain-English summary
CareFusion 213, LLC is recalling BD PurPrep (Povidone-iodine 8.3% w/w with isopropyl alcohol 72.5% w/w) 50 x 26 mL applicators due to a lack of assurance of sterility. Unsterilized applicators that were intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel.
The product was distributed nationwide in the USA. The affected lot is 4298581, which expires 09/30/2026. The product is a topical antiseptic solution used for skin preparation prior to medical procedures.
Consumers or healthcare facilities that have received PurPrep applicators from lot 4298581 should not use them and should contact CareFusion 213, LLC for instructions on product return or replacement. The loss of sterility assurance means the product may not be suitable for its intended medical use.
The recalled product
- Product
- PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
- Brand
- PURPREP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
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 (2)
- Lot: 4298581
- expires: 09/30/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
Same brand · PURPREP
- SevereBD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall
FDA (Drugs) · 2026-05-13
- SeverePurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-13
Same manufacturer · CareFusion 213, LLC
See all →- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
Same hazard · lack of sterility
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FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
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- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
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Similar recalls
- SevereBD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall
FDA (Drugs) · 2026-05-13
- SeverePurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateCareFusion Recalls Povidone Iodine Applicators Due to Sterility Labeling Errors
FDA (Drugs) · 2013-04-03
- ModerateCareFusion Recalls Misbranded Isopropanol Applicators Due to Sterility Labeling
FDA (Drugs) · 2013-04-03
- ModerateCareFusion Recalls SEPP 2% Iodine Tincture Applicators for Sterility Mislabeling
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- SevereChloraPrep One-Step Topical Solution Sterility Assurance Recall
FDA (Drugs) · 2026-07-01