The Recall Desk
ModerateFDA (Drugs)·D-0658-2024·Announced 2024-09-18

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.

What this means for you

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
Hazard
  • mis-labeling

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

Distributed nationwide across the United States.