FDA Drugs recall ·

Povi-One, 10% Povidone-Iodine Oral Antiseptic… recall

Recall number
D-0627-2026
Date
(initiated June 4, 2026)
Company / brand
Elevate Oral Care
346 Pike Rd Ste 5, West Palm Beach, FL, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
8132 6-packs & 2262 2-packs
Hazard tags
Potency
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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.

Why was it recalled?

sub potency

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Nationwide

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0627-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.