West Palm Beach, FL, United States
Elevate Oral Care recalls
2 recalls recorded since 2018, most recently on 4 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 4 June 2026
- Reason
- sub potency
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0627-2026
- Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
Terminated Class III Drugs
- Recall started
- 20 August 2024
- Terminated
- 5 August 2025
- Reason
- LABELING: LABEL MIX-UP.
- Distribution
- 120 direct customers, Nationwide US. No foreign, DOD/VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.