Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pik… recall
FDA recall D-0627-2026 · initiated Jun 4, 2026
Elevate Oral Care recalled Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… in Jun 2026 — an FDA Class II recall (D-0627-2026) because sub potency.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
sub potency
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8132 6-packs & 2262 2-packs
Details
- 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.
- Recalling company
- Elevate Oral Care
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Jun 4, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… recalled?
- Elevate Oral Care recalled Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… in Jun 2026 — an FDA Class II recall (D-0627-2026) because sub potency. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… recalled?
- Per the FDA enforcement record, the reason for recall D-0627-2026 was: sub potency
- Is a recalled Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL… are affected?
- Distributed: Nationwide. The recall covers these 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0627-2026.