Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Dharma Cavity Varnish with Fluoride Recalled by Dharma Research, Inc. Due to During an FDA inspection, it was found that...

Date: September 29, 2014
Company: Dharma Research, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dharma Research, Inc. directly.

Affected Products

Dharma Cavity Varnish with Fluoride

Quantity: 2,842

Why Was This Recalled?

During an FDA inspection, it was found that the products are being marketed without a cleared 510k.

Where Was This Sold?

This product was distributed to 4 states: CA, FL, IL, PA

Affected (4 states)Not affected

About Dharma Research, Inc.

Dharma Research, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report