The U.S. Food and Drug Administration (FDA) has escalated its response to a recent chocolate recall due to undeclared hazelnuts, assigning its highest risk classification.
A Class I recall signifies the potential for "serious adverse health consequences or death" if the product is consumed by individuals with a hazelnut allergy.
According to the FDA, even trace amounts of allergens can result in life-threatening reactions for sensitive individuals.
A Class I risk level alert has been issued for Fran's Pure Bar Almondmilk Chocolate 46 percent Madagascar Plant-Based product for containing undeclared hazelnuts.
The recall highlights the critical importance of accurate food labeling and the persistent risk that undeclared allergens pose to consumers in the United States.
On December 20, Fran's Chocolates, Ltd. of Seattle, Washington voluntarily recalled 112 units of the product (net wt. 1.1oz, UPC 7 49668 24280 2).
The recall was initiated after a supplier notified Fran's that the Almondmilk chocolate ingredient tested positive for trace amounts of hazelnuts due to processing on shared equipment with other nut-containing products.
It applies to bars sold between October 9, 2025, and December 15, 2025, at four Fran's Chocolates stores in Seattle and online at www.frans.com.
The FDA classified the recall as Class I -- the agency's most serious level -- on January 14, 2026, following reports of one adverse allergic event.
No illnesses or deaths related to other Fran's products have been reported as of the recall date.
The product's packaging did not disclose the presence of hazelnuts, thereby posing the risk of severe or potentially fatal reactions for those with hazelnut allergies.
Consumers with the product are warned not to eat it and to return it to the place of purchase for a full refund.
The recall was announced through multiple channels, including email, fax, letters, press releases, and direct store communication.
For further information about the affected product, regulatory status, and recall logistics, consumers can consult the FDA's official recall database or contact Fran's Chocolates at customercare@frans.com or 1-800-422-3726, Monday through Friday, 7:30 a.m. - 5:00 p.m. PST.
According to the official Fran's Chocolates announcement published by the FDA, "A supplier informed us that their Almondmilk chocolate ingredient tested positive for trace amounts of hazelnuts because it was processed on the same equipment with other products.
"We have received a report of one adverse allergic event. No reports of illness or death have been reported on other Fran's products to date."
The FDA says: "Class I... indicates a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Fran's Chocolates continues to communicate with affected consumers and the FDA; no end date for the recall has been set.