Class II · ModerateActive recall
Purprep
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of assurance of Sterility: potential product contamination
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byCareFusion 213 LLC
| Brand name | PURPREP |
| Generic name | POVIDONE IODINE AND ISOPROPYL ALCOHOL |
| Active ingredient(s) | ISOPROPYL ALCOHOL, POVIDONE-IODINE |
| Distributed by / for | CareFusion 213, LLC |
| NDC | 54365-014-42 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | CareFusion 213, LLC |
| Distribution | Nationwide in the USA |
| Recall initiated | 2026-04-22 |
| Report date | 2026-05-13 |
| Recall completed | — |
| Recall number | D-0517-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | El Paso TX United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.