FDA DrugsClass II
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL...
Published: July 1, 2026Recall ID: D-0627-2026Category: drugsCountry: US
Reason for Recall / Hazard
sub potency
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | West Palm Beach |
| State | FL |
| Openfda › Nui › 1 | N0000175486 |
| Openfda › Nui › 2 | M0011640 |
| Openfda › Unii | 85H0HZU99M |
| Openfda › Route | TOPICAL |
| Openfda › Spl id | 3f1914a6-3095-23c3-e063-6294a90ac03a |
| Openfda › Brand name | POVI-ONE |
| Openfda › Spl set id | f5252b4f-5e14-509e-e053-2995a90a6db8 |
| Openfda › Package ndc | 57511-0611-1 |
| Openfda › Product ndc | 57511-0611 |
| Openfda › Generic name | POVIDONE-IODINE 10% TOPICAL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs | Iodine [CS] |
| Openfda › Substance name | POVIDONE-IODINE |
| Openfda › Pharm class epc | Antiseptic [EPC] |
| Openfda › Manufacturer name | Elevate Oral Care |
| Openfda › Application number | M022 |
| Openfda › Original packager product ndc | 68599-3500 |
| Event id | 99191 |
| Address 1 | 346 Pike Rd Ste 5 |
| Address 2 | Suite 1, 5, 13, & 23 |
| Code info | Lots 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. |
| Postal code | 33411-3819 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 8132 6-packs & 2262 2-packs |
| Reason for recall | sub potency |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Overview
- Recalling FirmElevate Oral Care
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide