ByHeart Infant Formula Recalled in Canada Amid Botulism Concerns

The Canadian Food Inspection Agency (CFIA) has issued a recall for ByHeart Whole Nutrition Infant Formula following an outbreak of infantile botulism associated with the product in the United States. This recall specifically affects the 238g and 680g sizes of the formula, which is sold online. Consumers are advised against consuming or distributing these products due to the potential presence of the Clostridium botulinum toxin.

The CFIA has emphasized that the toxin may not be detectable by appearance or odor, yet it poses serious health risks. In infants, food-borne botulism can lead to symptoms such as difficulty swallowing, slurred speech, general weakness, and paralysis. Adults may experience facial paralysis, unreactive pupils, blurred vision, and difficulty speaking, among other symptoms. Notably, botulism does not typically cause fever, and in severe cases, it can be fatal.

Currently, no illnesses related to ByHeart formula have been reported in Canada. The recall originated from the Food and Drug Administration (FDA) in the United States, which initially flagged the product. The recall was voluntarily expanded by ByHeart to include all batches of the infant formula sold in the U.S. The CFIA’s warning in Canada is a direct response to this expansion.

As of now, the FDA is conducting tests on the product. To date, no unopened ByHeart products tested have shown positive results for Clostridium botulinum spores. The CFIA is also undertaking a food safety investigation that may lead to additional recalls.

Since August 2023, at least 23 cases of botulism have been confirmed or suspected in infants in the United States who consumed ByHeart formula. Families of two affected infants have initiated lawsuits against the company in federal courts across two states, citing health complications linked to the recalled product.

The CFIA continues to monitor the situation closely, and consumers are encouraged to stay informed regarding any updates related to this recall.