The U.S. Food and Drug Administration (FDA) assigned its second-highest risk warning to 4,665,608 units of a recalled frozen dessert distributed by Danone.
Since then, the FDA assigned its second-highest risk alert to the sweet treat.
“As a Class II recall, this means the risk is temporary or medically reversible adverse health consequences,” registered dietitian nutritionist Tiffany Bruno told NTD.
A Class 1 recall is defined as having a reasonable probability that the use of or exposure to will cause serious adverse health consequences or death, while a Class 3 event involves products that violate regulations but are unlikely to cause health problems, such as minor labeling errors.
The one-pint containers were distributed in the U.S. nationwide and in Canada.
“So Delicious Dairy Free® is working swiftly with retail partners to remove the potentially impacted product from shelves,” the FDA said. “In the meantime, the company has already identified and corrected this issue and will soon be able to bring back the frozen dessert so many people enjoy.”
Danone company leaders did not respond to requests for comment by the time of publication.
The ice cream alternative is sold at retail stores across the country and marketed as plant-based and dairy-free under the So Delicious brand.
Although packaging for the Salted Caramel Cluster frozen dessert changed in February 2025, each recalled pint bears the SKU number 136603 and UPC 744473476138.
Only the Salted Caramel Cluster flavor in pint-size containers with best-by dates before Aug. 8, 2027, are under recall and is not applicable to other So Delicious Dairy Free products, flavors, or production codes.
“So Delicious Dairy Free takes every consumer experience seriously and is initiating this voluntary recall in line with its commitment to product quality and consumer safety,” the FDA reads.