El Mirasol, Inc., one of Florida’s largest tortilla manufacturers, has initiated a voluntary recall of its Tortilla de Harina products due to the presence of an undeclared allergen—wheat. The U.S. Food and Drug Administration (FDA) has classified this recall as Class II, indicating that the consumption of the affected products could cause temporary or medically reversible adverse health consequences, with a remote probability of serious health issues.

Details of the Recall: The recall affects 50 cases, each containing 20 packages of 10 tortillas. The packages are clear plastic bags, each containing 400 grams of tortillas. The specific lot numbers affected are 012324120800, with an expiration date of February 23, 2024, and 021924120800, with an expiration date of March 19, 2024. These products were exclusively distributed within Florida.

The undeclared wheat poses a risk to individuals with wheat allergies and those with celiac disease. Wheat allergy can trigger symptoms such as hives, rash, nausea, stomach cramps, diarrhea, and in severe cases, anaphylaxis. For individuals with celiac disease, consuming gluten-containing products can lead to an adverse immune response, causing damage to the stomach lining and resulting in symptoms like diarrhea, fatigue, weight loss, bloating, nausea, constipation, and anemia.

FDA Recall Classification: The FDA classifies food and soft drink recalls based on the health hazard they pose:

• Class I: Severe risk with the potential for serious adverse health consequences or death.
• Class II: Moderate risk with potential for temporary or medically reversible adverse health consequences.
• Class III: Low risk with unlikely adverse health consequences.

Consumer Guidance: Consumers who have purchased the recalled tortillas should not consume them. Instead, they should either dispose of the product or return it to the place of purchase for a refund. For further information, consumers can contact El Mirasol, Inc. directly.

El Mirasol, Inc. has not yet provided a comment regarding the recall. The company initiated the recall on April 29, but the FDA only classified it on June 17. The classification highlights the importance of identifying and managing potential food allergens to protect public health.

For more information, consumers are encouraged to visit the FDA’s official recall notice and stay informed about the products they consume to ensure their safety.