FDA recall, , Moderate risk
Povi-One, 10% Povidone-Iodine Oral Antiseptic
Povi-One, 10% Povidone-Iodine Oral Antiseptic has sub potency.
Summary by Recall Canary from the FDA notice
What happened
Elevate Oral Care, of West Palm Beach, Florida, recalled Povi-One, 10% Povidone-Iodine Oral Antiseptic, packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, because of sub potency. The company began the recall on June 4, 2026, and it was added to the FDA's Enforcement Report on June 25, 2026, with nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Povi-One, 10% Povidone-Iodine Oral Antiseptic
- NDC
- 57511-0611-1
- Lot code
- PO062402
- PO072401
- PO092401
- PO102401
- PO102402
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- Elevate Oral CareWest Palm Beach, Florida
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99191
- Recall number
- D-0627-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
