Overview

• On September 19, Argentina’s regulator issued a new alert that reinforces Disposición Nº 5126/2025, keeping the product off the market in all presentations, sizes and lots.
• Argentine notices continued after the July withdrawal, prompting the reminder that use, distribution and commercialization remain prohibited nationwide.
• Brazilian authorities and experts reported almost 11,500 adverse cases linked to a product with identical formula, origin and manufacturing plant to the version sold in Argentina.
• Reported effects include oral lesions, pain, burning or tingling, gingival inflammation and swelling of the lips, with users citing medical costs and functional difficulties.
• Classified by ANMAT as a cosmetic, the toothpaste lacks therapeutic benefit that would warrant tolerating adverse effects, and the agency directs consumers to report reactions via its cosmetovigilance form or at [email protected].