Oral antiseptic Recall: Elevate Povi-One 10% Povidone-Iodine
Announced 2026-07-01 · FDA
FDA is recalling Elevate Oral Care Povi-One, 10% Povidone-Iodine Oral Antiseptic (NDC 57511-0611-1) produced by Elevate Oral Care, LLC for sub potency. Affected lots are PO062402 (Exp 6/30/2026), PO072401 (Exp 7/30/2026), PO092401 (Exp 9/30/2026), PO102401 (Exp 10/31/2026), and PO102402 (Exp 10/31/2026). The product was distributed nationwide and no corrective action is specified.
| Brand | Elevate Oral Care |
|---|---|
| Product | 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. |
| Reason | sub potency |
| Severity | moderate |
| Units affected | 8132 |
| Distribution | Nationwide |
| Agency | FDA |
| Recall / campaign no. | 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. |
WHAT YOU SHOULD DO
- Stop using any product from the affected lots PO062402, PO072401, PO092401, PO102401, or PO102402.
- Check your packaging for the listed lot numbers and expiration dates; if matched, discard the product or return per Elevate Oral Care instructions.
- Contact Elevate Oral Care at 346 Pike Road, Suite 6, West Palm Beach, FL 33411 for disposal, replacement, or refund instructions.
- If you experienced adverse effects, consult a healthcare professional and report to the FDA as appropriate.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.