FDA recall D-0627-2026

Elevate Oral Care · Class II · drug

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 for recall

sub potency

Distribution

Nationwide

Key facts

Status
Ongoing
Initiation date
2026-06-04
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Palm Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2026