FDAClass II · Drug · Recalled July 1, 2026

Povi-One recall — Elevate Oral Care

Hazard: sub potency

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0627-2026
Brand: Elevate Oral Care
Classification: Class II
Units affected: 8132 6-packs & 2262 2-packs
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Povi-One

Companies & origin

Recalling firm location: West Palm Beach, FL, United States
Firm address: 346 Pike Rd Ste 5, Suite 1, 5, 13, & 23, 33411-3819

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Distribution: Nationwide
Firm notified the public via: Letter
FDA event ID: 99191
Recall initiated: June 4, 2026
FDA classified: June 25, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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