Class III · Low risk
Sensodyne PRONAMEL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Just Right 5000
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
LABELING: LABEL MIX-UP.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
57511-0002-01
Compare with the code on your package — it is the most precise check available.
Drug: Fluoride
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Just Right 5000 1.1% Sodium Fluoride Toothpaste NDC 57511-0002 |
SODIUM FLUORIDE 1.1 g/100g | Gel, Dentifrice Topical |
Elevate Oral Care | Rx |
- Recalling firm
- Elevate Oral Care
- NDC code
- 57511-002-1
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0658-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluoride recalls
See all
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Other recalls by Elevate Oral Care
All 2024 recalls
Class II · Moderate risk
Povi-One
sub potency
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.