Lower riskDrug recall · FDA · Published June 4, 2026
Elevate Povi-One 10% Povidone-Iodine Oral Antiseptic: Sub Potency Risk
Elevate Oral Care recalls Povi-One 10% Povidone-Iodine oral antiseptic due to sub potency. Affected lots have NDC 57511-0611-1 and specific expiration dates. Consumers should check product labels for these identifiers.
“Elevate Povi-One 10% Povidone-Iodine Oral Antiseptic: Sub Potency Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31222-elevate-povi-one-10-povidone-iodine-oral-antiseptic-sub-potency. Based on FDA recall #D-0627-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0627-2026%22&limit=1).
The FDA announced on June 4, 2026, that Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency hazards. Owners should contact the company for a refund.
The product poses a sub-potency hazard, meaning the active ingredient may not be strong enough to function as intended.
Context
GovInfoNow's records show Elevate Oral Care has one other recall on record since August 20, 2024, specifically for Just Right 5000 Toothpaste due to a labeling error. Other recent recalls of similar products include ImprimisRx Povidone Iodine Ophthalmic Solution Recall (August 24, 2026), Bell Pharmaceuticals CAREone 6.5% Carbamide Peroxide Recall (June 25, 2026), and Teva Amoxicillin Clavulanate Suspension Recall (October 13, 2025).
How to tell if you have this one
Check the product label for the NDC number 57511-0611-1 and lot numbers PO062402 through PO102402 with specific expiration dates (June 30, 2026 through October 31, 2026).
Brand
Elevate Oral Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the NDC number 57511-0611-1 and lot numbers PO062402 through PO102402 with expiration dates from June 30, 2026 to October 31, 2026.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall does not require immediate action, but you should check the product label to confirm if it is affected. If it is, contact Elevate Oral Care for further instructions.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0627-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0627-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.