FDAFDA recall D-0627-2026 · Jul 1, 2026
Elevate Oral Care: Povi-One recall
Recall found
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Quantity
- 8132 6-packs & 2262 2-packs
- Distribution
- Nationwide
- Recalling firm
- Elevate Oral Care, West Palm Beach, FL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-04
Source: openFDA enforcement record D-0627-2026 · search recall number D-0627-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.