Class III · Low risk
Povi-One (Povidone-Iodine 10% Topical)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
sub potency
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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 NDC
57511-0611-01
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Povi-One Povidone-Iodine 10% topical NDC 57511-0611 |
POVIDONE-IODINE 1 mg/10mL | Liquid Topical |
Elevate Oral Care | OTC |
- Recalling firm
- Elevate Oral Care
- NDC code
- 57511-0611-1
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0627-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class III · Low risk
Just Right 5000
LABELING: LABEL MIX-UP.
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