FDA Launches Investigation into ByHeart Baby Formula After Illnesses

The U.S. Food and Drug Administration (FDA) has initiated a multistate investigation into ByHeart baby formula after at least 13 infants were hospitalized with botulism symptoms linked to the product. The investigation, announced on Saturday, encompasses reports from ten states, including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

The FDA has issued a warning advising against the use of specific lots of ByHeart Whole Nutrition Infant Formula. The affected lot numbers are 206VABP/251131P2 and 206VABP/251261P2, both of which are marked with a use by date of December 1, 2026. Consumers can find these numbers on the bottom of the cans. In response to the situation, ByHeart has agreed to voluntarily recall these products, which have been sold online and through major retailers across the country.

According to the FDA, the affected formula constitutes less than 1% of all baby formula sold in the United States, alleviating concerns about potential shortages. The agency recommends that anyone in possession of the recalled formula should note the lot numbers and dispose of the product safely. Fortunately, no fatalities have been reported, and the last documented case of illness occurred in November.

Botulism is a serious illness caused by a toxin that attacks the body’s nervous system. Symptoms in infants can include constipation, poor feeding, difficulty swallowing, and in severe cases, respiratory arrest. The FDA emphasizes that these symptoms may take weeks to develop after exposure to the toxin. Parents and caregivers are encouraged to contact their healthcare provider if their infants exhibit any signs of illness.

As the investigation continues, health officials are focusing on understanding the source of the contamination and preventing further cases. The FDA is working closely with state health authorities to monitor the situation and provide updates as necessary.