The U.S. Food and Drug Administration (FDA) assigned its highest risk alert to 234 candy bars sold in two states due to the potential presence of undeclared allergens.
Zingerman’s Candy Manufactory of Ann Arbor recalled Zingerman’s Peanut Butter Crush and Zingerman’s Ca$hew Cow full-size bars last month because they may contain cashews and peanuts that are not listed as ingredients, according to a Nov. 10 enforcement report.
The FDA designated the recall a Class 1 event, which is the federal government’s highest risk alert and is described on the FDA website as having a reasonable probability that the use of or exposure will cause serious adverse health consequences or death.
"Level 1 recalls are done out of an abundance of caution because the consumption of the product could cause serious health issues, or even death,” Mendocino Food Consulting founder Bryan Quoc Le told NTD.
A Class 2 event is described on the FDA website as exposure to a product that may cause temporary or medically reversible adverse health consequences, while a Class 3 event involves products that violate regulations but are unlikely to cause health problems, such as minor labeling errors.
Company leaders did not respond to requests for comment about the high-risk classification by the time of publication.
An Oct. 27 FDA advisory said the sweet treat was distributed to consumers through Michigan and New York retailers and attributed the labeling error to a temporary breakdown in the production and packaging processes.
There are nine major food allergens that the FDA requires all companies to identify in their products. They include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
In people who have food allergies, an immune system overreaction to exposure can cause a life-threatening condition called anaphylaxis.
Almonds, Brazil nuts, cashews, filberts, hazel nuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts are all considered tree nuts by the FDA.
According to the Mayo Clinic, anaphylaxis can result in blockages or narrowing of the breathing airways.
Zingerman's Candy Manufactory production manager Jamie LeBoeuf previously told NTD that 156 Peanut Butter Crush Bars and 78 Ca$hew Cow candy bars from a single lot #174250 were affected by the recall and that 12 Peanut Butter Crush Bars and 12 Cashew Cow bars were sent to specialty retailers in New York.
"All of the retailers receiving the affected candy bars have been notified, the affected candy bars have been removed from sale and many returned to us," LeBoeuf said on Oct. 28. "We take food safety very seriously, and have implemented additional training, manual checks, and protocols in our manufacturing process to ensure that the problem that caused this cross contamination cannot recur."