Food allergen recalls have surged over the past five years, becoming one of the most common causes of food product recalls in North America. In 2023 alone, the FDA and USDA recalled hundreds of food products due to undeclared allergens—mistakes that can cost companies millions and put lives at risk.

The Food Safety Modernization Act (FSMA) has been shaping the regulatory landscape for years, but Rule 204, finalized by the FDA in 2022 and going into effect in January 2026, is one of the most impactful updates for food manufacturers and processors.