FDA Drug recall D-0658-2024
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…
- FDA Drug
- Class III
- terminated
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class III recall of 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… by Elevate Oral Care, citing LABELING: LABEL MIX-UP.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0658-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-08-20 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Elevate Oral Care |
| Distribution | US |
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
LABELING: LABEL MIX-UP.
Identifiers
| code_info | Lot #G073DC, Exp 3/31/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0658-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.