The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0801-2023·Announced 2023-05-10

Cargill Grain Product Recalled for Gluten Contamination Despite Gluten-Free Label

Cargill is recalling PROSANTE TVGPTN products labeled as gluten-free because they may contain gluten levels above 20 ppm. The recall affects 42,400 pounds distributed nationwide and internationally.

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: FDA Class II recall for allergen (gluten) mislabeling on a product labeled gluten-free. No illnesses or injuries reported in the source text, and the hazard is theoretical. Per the rubric, allergen mislabeling on common allergens without reported illness is classified as High (3).

Plain-English summary

Cargill, Inc is recalling PROSANTE TVGPTN 10P MNCD 25LB paper bags because the product may contain gluten levels above 20 ppm, despite bearing a gluten-free label. The recall affects 42,400 pounds of product.

The FDA permits gluten-free claims only on products containing 20 ppm or less of gluten. This product may exceed that threshold, creating a potential risk for consumers with celiac disease or gluten sensitivity.

The affected product was distributed nationwide in the United States and internationally to Canada, Chile, Costa Rica, Guatemala, Mexico, and the United Kingdom. The recalling firm is Cargill, Inc.

Consumers, particularly those with celiac disease or gluten sensitivity, should not consume this product. Those with questions should contact Cargill, Inc Corporate Headquarters.

The recalled product

Product
PROSANTE TVGPTN 10P MNCD 25LB BG/32P, paper bag
Manufacturer
Cargill, Inc Corporate Headquarters
Category
Food — Grain / Ingredient
Hazard

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Cargill, Inc Corporate Headquarters under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →

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