Just Right 5000 recall
FDA recall D-0658-2024 · initiated Aug 20, 2024
Elevate Oral Care recalled Just Right 5000 in Aug 2024 — an FDA Class III recall (D-0658-2024) because LABELING: LABEL MIX-UP.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
LABELING: LABEL MIX-UP.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Elevate Oral Care
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- 120 direct customers, Nationwide US. No foreign, DOD/VA.
- Initiated
- Aug 20, 2024
- FDA report date
- Sep 18, 2024
Frequently asked
- Was Just Right 5000 recalled?
- Elevate Oral Care recalled Just Right 5000 in Aug 2024 — an FDA Class III recall (D-0658-2024) because LABELING: LABEL MIX-UP. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Just Right 5000 recalled?
- Per the FDA enforcement record, the reason for recall D-0658-2024 was: LABELING: LABEL MIX-UP.
- Is a recalled Just Right 5000 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Just Right 5000 are affected?
- Distributed: 120 direct customers, Nationwide US. No foreign, DOD/VA.. The recall covers these lots — Lot #G073DC, Exp 3/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0658-2024.