CLASS II ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
Povi-One, 10% Povidone-Iodine Oral Antiseptic recalled
Elevate Oral Care is recalling Povi-One, 10% Povidone-Iodine Oral Antiseptic, distributed nationwide in the US. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0627-2026
- FDA event ID
- 99191
- Recalling firm
- Elevate Oral Care, West Palm Beach, FL
- Brand
- Povi-one
- Manufacturer
- Elevate Oral Care
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jun 2026
- FDA classified
- 25 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Jun 2026 | Recall initiated by company | |
| 25 Jun 2026 | Classified by FDA | +21 days |
| 1 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
sub potency
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
sub potency
Which lots are affected?
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.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Elevate Oral Care
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor recalled | Elevate Oral Care | Packaging Defects | Nationwide |
Other Povidone-iodine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS III | Readyprep PVP, Povidone-Iodine 10% Solution recalledPovidone-iodine | Medline Industries | Potency & Assay | Nationwide |