FDA-Drug2026-07-01Class IIMISBRANDING
Elevate Oral Care Povi-One povidone-iodine oral antiseptic recalled for sub-potency
LABEL MIX UPNationwide distribution
Elevate Oral Care Povi-One recalled for sub-potency
Elevate Oral Care's Povi-One 10% Povidone-Iodine Oral Antiseptic does not contain the full strength stated on the label. Five specific production lots distributed nationwide do not meet the required potency standard, which means the product may not work as intended for oral antiseptic purposes.
- Check if you have Povi-One with lot numbers PO062402, PO072401, PO092401, PO102401, or PO102402
- Stop using the product if you have one of these lots
- Contact Elevate Oral Care or your healthcare provider for guidance on alternatives
Hazard
sub potency
Sold states
Nationwide
Affected count
8132 6-packs & 2262 2-packs
Manufactured in
346 Pike Rd Ste 5, Suite 1, 5, 13, & 23, West Palm Beach, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0627-2026Don't want to check this manually?
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