FDA Class III Recall: Elevate Oral Care's Sodium Fluoride Product Pulled Due to Label Mix-Up
Elevate Oral Care has completed a Class III recall (D-0658-2024) of its Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor product. Initiated on August 20, 2024, the voluntary recall addressed a critical label mix-up affecting 120 direct customers nationwide. This event underscores the persistent risk of packaging errors in pharmaceutical supply chains, demanding robust quality control protocols from manufacturers and vigilant oversight from procurement teams.
FDA Action: Elevate Oral Care Initiates Class III Recall for Sodium Fluoride Product
On August 20, 2024, Elevate Oral Care initiated a voluntary, firm-initiated recall (D-0658-2024) for its dental therapeutic product, Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor. This action, classified by the FDA on September 12, 2024, as a Class III recall, was prompted by a critical label mix-up. For procurement directors and regulatory affairs heads, a Class III classification indicates that the product is unlikely to cause adverse health consequences, but the deviation from regulatory standards still represents a significant quality control failure. The specific affected lot identified was #G073DC, with an expiration date of March 31, 2026. This incident underscores the importance of rigorous quality assurance protocols in packaging operations, as even seemingly minor labeling errors can trigger extensive recalls and impact supply chain reliability. Businesses sourcing oral care pharmaceuticals must ensure their suppliers implement robust verification steps to prevent such discrepancies, safeguarding both product integrity and patient safety.
Elevate Oral Care's Product Scope and Distribution Footprint
The recalled product, Just Right 5000, is a 1.1% Sodium Fluoride formulation, presented in a Candy Apple Flavor, with a net weight of 3.4oz (97g) and designated for prescription use (Rx Only). Its National Drug Code (NDC) is 57511-002-1. The product is manufactured for Elevate Oral Care, LLC, based in West Palm Beach, Florida, specifically at 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, with the note that it is made in the U.S.A. with an imported pump. The distribution pattern for this specific lot was confined to 120 direct customers across the Nationwide US, with no foreign distribution or sales to the Department of Defense (DOD) or Veterans Affairs (VA). This contained distribution limits the immediate global supply chain impact, but procurement teams must still assess the implications for domestic sourcing. Understanding the manufacturing origin and component sourcing, such as the imported pump, is crucial for supply chain VPs to identify potential points of vulnerability and ensure comprehensive supplier due diligence extends beyond the primary manufacturer to critical component providers.
Regulatory Resolution and Industry Implications for Oral Care Sourcing
The FDA officially terminated the recall (D-0658-2024) on August 5, 2025, signaling that Elevate Oral Care has successfully addressed the labeling issue and removed affected products from the market. This termination provides clarity for business development executives and supply chain VPs regarding the product's current status and the company's compliance trajectory. While this specific event was a Class III recall, the broader regulatory environment demands constant vigilance. Recent parallel events, such as Essential Wellness Pharma's Class II recall for sterility failures or the FDA hearing impacting Amgen's Tavneos, highlight the diverse and persistent regulatory challenges across the life sciences sector. For procurement directors, this Elevate Oral Care recall serves as a reminder that even voluntary, firm-initiated actions for seemingly minor issues like label mix-ups can disrupt supply and necessitate immediate response. Establishing robust supplier qualification programs that include regular audits of labeling and packaging processes is paramount to mitigating future risks and ensuring uninterrupted supply of critical oral care products.