The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-0781-2023·Announced 2023-05-10

Prolia soy flour products recalled for undisclosed gluten content

Cargill is recalling multiple PROLIA soy flour products that carry gluten-free claims but may contain gluten above 20 ppm. Consumers with celiac disease or gluten sensitivity should not consume affected products.

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 recall involves mislabeling of gluten content on soy flour products marketed as gluten-free. Gluten is a common allergen posing risk to consumers with celiac disease and gluten sensitivity. The source text reports no illnesses or injuries, supporting a High severity rating per the FDA Class II classification and allergen-mislabeling criteria.

Plain-English summary

Cargill, Inc. is recalling multiple PROLIA soy flour products distributed in the United States, Canada, Chile, Costa Rica, Guatemala, Mexico, and the United Kingdom. The affected products carry gluten-free claims on their labeling but may contain gluten at levels exceeding 20 ppm, the threshold established for gluten-free food.

The recall involves approximately 40,536,866 pounds of soy flour distributed in bulk, bulk bags, and 50-pound paper bags. Consumers with celiac disease or gluten sensitivity who purchased these products should cease use immediately.

Affected consumers should not consume the recalled products. Those with questions or concerns should contact Cargill for additional information regarding their specific product codes. The FDA recall number is F-0781-2023.

The recalled product

Product
PROLIA SOY FLR 200/20 STD BLK, PROLIA SOY FLR 200/70 STD BLK, PROLIA SOY FLR 300/70 NT BLK, PROLIA SOY FLR 100/20 STD 1MT TT, PROLIA SOY FLR 100/90 STD 1500LB TT, PROLIA SOY FLR 100/90 NT 50LB BG, PROLIA SOY FLR 200/20 XTRA 50LB BG NGM, PROLIA SOY FLR 200/20 STD 50LB BG, PROLIA…
Manufacturer
Cargill, Inc Corporate Headquarters
Category
Food — Flour / Ingredients
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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