The U.S. Food and Drug Administration (FDA) assigned its highest risk this week to 866 bags of cake mix sold nationwide.
They include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
Since the recall was initially announced last year, the FDA assigned the bakery item its highest risk warning at Class 1.
A Class 1 event is defined on the FDA website as having a reasonable probability that the use of or exposure to will cause serious adverse health consequences or death, while Class 2 signals that the risk is temporary or adverse health consequences are medically reversible.
A Class 3 label involves products that violate regulations but are unlikely to cause health problems, such as minor labeling errors.
The recall is applicable to fifty-one 50-pound bags of Spice Cake Mix, 720 fifty-pound bags of Bread and Roll Mix, as well as 95 fifty-pound bags of Swiss Chocolate Cake Mix.
Ensuring that a production facility's Hazard Analysis and Critical Control Points systems are updated with the best practices and all staff are trained on implementing them is critical, according to registered dietitian nutritionist Tiffany Bruno.
“With AI increasingly taking over, it may minimize the risk of human error, but it also means a human isn’t there to detect a mechanical failure,” Bruno told NTD. “More real-time monitoring might be needed by qualified humans to oversee automated processes.”
Gregory’s Foods of Eagan, Minnesota, voluntarily withdrew its White Chocolate Macadamia Nut flavor of "Bag Full of Cookies” frozen cookie dough on December 19, 2025.
Since then, the FDA assigned its highest risk alert to the sweet treat.
“Frozen Monster Cookie Dough, which contains peanut, may be packaged in a bag that is labeled as White Chocolate Macadamia Nut,” FDA officials said.
There are six bags per case of 2-pound 8.5-ounce packages of the recalled cookie product that were distributed in Minnesota, Wisconsin, North Dakota and Nebraska in retail grocery stores and through distribution centers.
