In July 2025, Argentina's ANMAT ordered the immediate withdrawal of Colgate Total Clean Mint toothpaste from the market after over 11,000 adverse reaction reports in Brazil and 21 confirmed cases in Argentina. Consumers reported blisters, oral ulcers, burning sensations, swelling and pain after using the product.
Brazil's ANVISA had already issued a preventive ban on all batches in March 2025, after recording 11,441 adverse reaction reports between July 2024 and June 2025, including 40 classified as severe. The toothpaste, imported from Brazil, had been reformulated with stannous fluoride instead of sodium fluoride — a change regulators linked to the reactions, possibly worsened by a new flavouring agent.
Colgate-Palmolive commissioned an in vitro study suggesting that a flavouring agent may have compromised oral mucosa cell integrity. The company initially refused to voluntarily withdraw the product in Argentina, forcing ANMAT to issue a mandatory ban. All lots were removed from sale until Colgate could provide evidence of safety.
A nationwide sales ban followed 11,000+ injury reports, causing significant brand damage.
A formula change — switching to stannous fluoride — was made without adequate safety testing for the specific flavouring interaction that appears to have caused the injuries.
Colgate resisted voluntary withdrawal in Argentina even after Brazil's ANVISA had already banned the product, forcing regulators to escalate to a mandatory ban.
Post-market surveillance in Brazil found the problem within months but did not trigger a faster global response — the same product stayed on shelves in Argentina for months after Brazil's ban.
A formula change to a product used by millions every day is not a minor tweak — it is a new product in regulatory terms. When one regulator bans it, every market that still sells it is a liability.
Argentina's ANMAT banned all lots of Colgate Total Clean Mint, requiring safety evidence before the product could return. Brazil's ANVISA had issued a similar ban months earlier. Colgate was forced to investigate the flavouring agent interaction and reformulate.
FOLLOW THE EVIDENCE