Povi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency
Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall for sub potency of a topical oral antiseptic with no reported illnesses or injuries. Sub potency represents reduced effectiveness rather than direct harm, and the absence of adverse event reports supports a moderate classification.
Plain-English summary
Elevate Oral Care, LLC is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic (NDC 57511-0611-1) distributed nationwide due to sub potency. The recall affects 8,132 6-packs and 2,262 2-packs of the product.
The affected lots are PO062402 (Exp 6/30/2026), PO072401 (Exp 7/30/2026), PO092401 (Exp 9/30/2026), PO102401 (Exp 10/31/2026), and PO102402 (Exp 10/31/2026). The product is manufactured and packaged by Elevate Oral Care, LLC, located at 346 Pike Road, West Palm Beach, FL 33411.
This is a voluntary recall initiated by the firm on June 4, 2026. Consumers who have purchased affected lots should stop using the product and consult with a healthcare provider if they have questions about their use of this product.
The recalled product
- Product
- POVI-ONE (POVIDONE-IODINE 10% TOPICAL)
- Brand
- POVI-ONE
- Manufacturer
- Elevate Oral Care
- Category
- Drug — Topical Oral Antiseptic
- Hazard
- sub-potency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Distributed nationwide across the United States.
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