Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Bea
Summary
The FDA issued a Class II for Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL by Elevate Oral Care. Reason: sub potency.
Details
Source
Drug Recall
External ID
D-0627-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: 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.
Quantity Affected: 8132 6-packs & 2262 2-packs
Reason for Recall
sub potency
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-04
Company
West Palm Beach, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 60 drug-related FDA actions this month.
Elevate Oral Care has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elevate Oral Care) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elevate Oral Care have FDA actions?
Elevate Oral Care has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0627-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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