The Canadian Food Inspection Agency (CFIA) has issued a recall for ByHeart Whole Nutrition Infant Formula due to a potential risk of botulism. This action follows an outbreak of infantile botulism linked to the product in the United States. The CFIA advises consumers not to use the 238-gram and 680-gram sizes of the formula, which are sold online, as they may contain the Clostridium botulinum toxin.

The CFIA warns that contaminated food may not show visible signs of spoilage, such as changes in appearance or smell, yet it can still pose serious health risks. Symptoms of food-borne botulism in children can include difficulty swallowing, slurred speech, general weakness, and paralysis. In adults, symptoms may manifest as facial paralysis, unreactive pupils, blurred vision, and difficulty speaking or swallowing. Notably, botulism does not typically cause a fever, and in severe cases, it can lead to death.

Currently, no illnesses related to this product have been reported in Canada. The recall was prompted by the U.S. Food and Drug Administration (FDA), which is conducting tests on the product. So far, no unopened ByHeart products tested have shown positive results for Clostridium botulinum spores. However, the CFIA is conducting its own food safety investigation, which may lead to additional recalls.

Since August, at least 23 cases of botulism have been confirmed or suspected in infants in the U.S. who consumed ByHeart formula. Families of two affected infants have filed lawsuits against the company. The CFIA has provided UPC codes for the recalled products: 8 50044 96800 and 8 50044 96802, and it includes all unexpired “Use By” codes purchased online. Parents who suspect their child may have consumed the affected formula are urged to contact their healthcare provider for guidance.