Recall Ledger

Povi-One recall (Elevate Oral Care)

DrugClass IIOngoing

Summary: Elevate Oral Care is recalling 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.

What is being recalled

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.

Why

sub potency

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide

How to tell if yours is affected

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 to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0627-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 4, 2026
ReportedJuly 1, 2026
CompanyElevate Oral Care
Company locationWest Palm Beach, FL, United States
Initiated byVoluntary: Firm initiated
Quantity8132 6-packs & 2262 2-packs

More recalls from Elevate Oral Care · all drug recalls · recalls from June 2026

Official FDA record