Overview
- ANMAT’s Disposition 5126/2025 took effect July 23, prohibiting use, distribution and sale of Colgate Total Clean Mint throughout Argentina until Colgate-Palmolive Argentina provides conclusive safety data.
- Brazil’s health regulator ANVISA ordered a voluntary nationwide recall in March after logging over 11,000 reversible oral injury reports, including blisters and ulcers linked to the toothpaste.
- In Argentina, Colgate-Palmolive reported 19 nonserious adverse events by July 7 and ANMAT’s Cosmetovigilance system received two additional complaints.
- Company-provided in vitro studies suggest the newly added flavoring agent may disrupt oral cell membranes and directly cause mucosal irritation.
- ANMAT continues active monitoring and urges consumers to report any further oral reactions via its online vigilance portal.