CLASS III Drug recall · Reported 18 Sep 2024 · FDA Enforcement Report
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor recalled
Elevate Oral Care is recalling Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, distributed nationwide in the US. The recall was initiated on 20 Aug 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0658-2024
- FDA event ID
- 95219
- Recalling firm
- Elevate Oral Care, West Palm Beach, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Aug 2024
- FDA classified
- 12 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 20 Aug 2024 | Recall initiated by company | |
| 12 Sep 2024 | Classified by FDA | +23 days |
| 18 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
LABELING: LABEL MIX-UP.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
120 direct customers, Nationwide US. No foreign, DOD/VA.
Questions about this recall
Why was it recalled?
LABELING: LABEL MIX-UP.
Which lots are affected?
Lot #G073DC, Exp 3/31/2026
Where was it sold?
120 direct customers, Nationwide US. No foreign, DOD/VA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Elevate Oral Care
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one | Elevate Oral Care | Potency & Assay | Nationwide |