FDAFDA recall D-0644-2026 · Jul 8, 2026
CareFusion 213, LLC: BD PurPrep recall
Recall found
Product
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Reason for recall
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: 4298581, expires: 09/30/2026.
- Quantity
- N/A
- Distribution
- Distributed Nationwide in the USA
- Recalling firm
- CareFusion 213, LLC, El Paso, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-11
Source: openFDA enforcement record D-0644-2026 · search recall number D-0644-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.