FDA recall, , Moderate risk
BD PurPrep Povidone-Iodine and Isopropyl Alcohol Antiseptic Solution
BD PurPrep sterile solution may lack assurance of sterility due to potential contamination.
Summary by Recall Canary from the FDA notice
What happened
CareFusion 213, LLC, of El Paso, Texas, recalled BD PurPrep sterile solution on April 22, 2026, due to lack of assurance of sterility from potential product contamination. The FDA added the recall to its Enforcement Report and classified it on May 5, 2026, with the weekly report on May 13, 2026. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Product details
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co
- NDC
- 54365-014-41
- Lot code
- 4263873
- 08-31-2026
- 4320590
- 09-30-2026
- 4320591
- 10-31-2026
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912
- NDC
- 54365-014-42
- Lot code
- 4258309
- 4260329
- 4256875
- 08-31-2026
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- CareFusion 213, LLCEl Paso, Texas
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98790
- Recall numbers
- D-0517-2026 to D-0518-2026
All recalls from CareFusion 213, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
