Just Right 5000 — Class III drug recall D-0658-2024
Terminated recall by Elevate Oral Care, reported 2024-09-18, distributed nationwide. LABELING: LABEL MIX-UP.
| Recall number | D-0658-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elevate Oral Care, West Palm Beach, FL, United States |
| Recall initiated | 2024-08-20 |
| Classified | 2024-09-12 |
| Reported by FDA | 2024-09-18 |
| Terminated | 2025-08-05 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | G073DC |
| Expiration dates | 2026-03-31 |
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
Reason for recall
LABELING: LABEL MIX-UP.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0658-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.