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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
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 23, 2026 at 11:04 PM UTC.
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