Fluoride Dental Product Recalled Due to Label Mix-Up
Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class III recall with a label mix-up and no reported illnesses or injuries. Per the severity rubric, FDA Class III recalls are typically scored 1-2, and label mix-ups constitute minor labeling errors, warranting a Moderate rating.
Plain-English summary
Just Right 5000, a 1.1% sodium fluoride dental product in Candy Apple flavor, is being recalled by Elevate Oral Care, LLC due to a label mix-up.
The recalled product is lot #G073DC, expiring March 31, 2026. The product was distributed to 120 direct customers nationwide. Elevate Oral Care is located at 346 Pike Rd, Suite 5, West Palm Beach, FL 33411.
Consumers who have this product should seek guidance from Elevate Oral Care or their healthcare provider.
The recalled product
- Product
- Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
- Manufacturer
- Elevate Oral Care
- Category
- Drug — Oral Care
- Hazard
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 (2)
- Lot #G073DC
- Exp 3/31/2026
Distribution
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