Class II · ModerateActive recall
Povi-One
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.
Where it was soldNationwide
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 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 byElevate Oral Care
| Brand name | POVI-ONE |
| Generic name | POVIDONE-IODINE 10% TOPICAL |
| Active ingredient(s) | POVIDONE-IODINE |
| Distributed by / for | Elevate Oral Care |
| NDC | 57511-0611-1 |
Show the full FDA record
| Full product label | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. |
| Recalling firm | Elevate Oral Care |
| Distribution | Nationwide |
| Quantity | 8132 6-packs & 2262 2-packs |
| Recall initiated | 2026-06-04 |
| Report date | 2026-07-01 |
| Recall completed | — |
| Recall number | D-0627-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | West Palm Beach FL 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.