Medications & Supplements/Prescription Drugs

Just Right 5000 Sodium Fluoride Toothpaste Recalled for Labeling Mix-Up

Agency Publication Date: September 12, 2024

Summary

Elevate Oral Care is recalling one lot of Just Right 5000 (1.1% Sodium Fluoride) toothpaste in Candy Apple flavor. The recall was initiated because of a labeling mix-up on the 3.4-ounce (97g) prescription-only containers. If you have used this product and have health concerns, you should contact your dentist, pharmacist, or healthcare provider.

Risk

A label mix-up can lead to consumers using the medication incorrectly or receiving inaccurate information about ingredients, potentially resulting in an adverse reaction or ineffective treatment.

What You Should Do

This recall involves Just Right 5000 (1.1% Sodium Fluoride) Candy Apple flavor toothpaste sold in 3.4-ounce (97g) pumps with NDC 57511-002-1.
Identify the affected product by checking for lot number G073DC with an expiration date of 3/31/2026 printed on the packaging.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Elevate Oral Care for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Just Right 5000 (3.4 oz)

Variants: 1.1% Sodium Fluoride, Candy Apple Flavor, Rx Only

Lot Numbers:

G073DC (Exp 3/31/2026)

NDC:

57511-002-1

Recall #: D-0658-2024. Manufactured for Elevate Oral Care, LLC with imported pump.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95219

Status: Resolved

Manufacturer: Elevate Oral Care

Sold By: 120 direct customers

Manufactured In: United States

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Just Right 5000 (1.1% Sodium Fluoride) Candy Apple flavor toothpaste sold in 3.4-ounce (97g) pumps with NDC 57511-002-1.

Identify the affected product by checking for lot number G073DC with an expiration date of 3/31/2026 printed on the packaging.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Elevate Oral Care for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.