Arillis Tortillas Recalled Due to Undeclared Wheat Allergen
Arillis Corp is recalling Tortillas Arillis due to undeclared wheat. Consumers with wheat allergies may be at risk if they consume the product.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves mislabeling of a common allergen (wheat). Undeclared wheat poses a direct health risk to consumers with wheat allergies; no illnesses or injuries are reported in the source.
Plain-English summary
Arillis Corp is recalling Tortillas Arillis, packaged as 10 tortillas per packet, due to undeclared wheat. The product was distributed for domestic consumption only.
Wheat is a major allergen, and the failure to declare it on the product label poses a health risk to consumers with wheat allergies or sensitivity. Consumers who have this product and are allergic or sensitive to wheat should not consume it.
If you have purchased this product, check your home and do not consume it if you or anyone in your household has a wheat allergy or sensitivity. Contact Arillis Corp for information on returning or disposing of the product, or contact the U.S. Food and Drug Administration for additional guidance.
The recalled product
- Product
- Tortillas Arillis, Arillis Corp, Contains: 10 (ten) tortillas
- Manufacturer
- ARILLIS CORP
- Category
- Food — Grain
- Hazard
- Affected units
- 300
Distribution
Distribution scope not specified by the agency.
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