← FDA ENFORCEMENT
D-0658-2024Class III

Elevate Oral Care

Recalling firm
Elevate Oral Care
Product type
Drug
Status
Terminated
Report date
2024-09-18
Distribution
120 direct customers, Nationwide US. No foreign, DOD/VA.
Firm state
FL
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

LABELING: LABEL MIX-UP.

Product description

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

Code / lot info

Lot #G073DC, Exp 3/31/2026

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class IIDaavlin Distributing Company2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.