Investigation Ongoing into Infant Botulism Cases Linked to ByHeart Formula

SACRAMENTO, California — The Centers for Disease Control and Prevention (CDC), alongside state public health officials and the U.S. Food and Drug Administration (FDA), are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. As of November 8, 2025, authorities reported 13 infants across ten states became ill after consuming the formula.

Botulism is a rare but serious illness caused by the toxin produced by the bacteria Clostridium botulinum. It can lead to symptoms such as constipation, poor feeding, and muscle weakness. Health officials have noted that the illness often begins with significant challenges in sucking and swallowing, leading to a weak cry in affected infants.

On the same day, ByHeart Inc. announced the voluntary recall of two lots of the Whole Nutrition Infant Formula. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2, both labeled for use by December 1, 2026. This formula, which comprises about 1% of U.S. infant formula sales, is sold both online and in major retailers nationwide, including Amazon and Walmart.

According to the FDA, the investigation revealed that 13 infants hospitalized across states—including Arizona, California, and Texas—reported feeding on ByHeart formula before becoming ill. Although the FDA has not confirmed a direct link between these cases and the formula, the recall is a precautionary measure.

The California Department of Public Health (CDPH) reported an uptick in type A botulism infections among infants consuming the formula since August 2025. Preliminary laboratory results suggest trace amounts of the botulinum bacteria were found in a can of the formula that was tested.

Health officials are urging parents to stop using ByHeart Whole Nutrition Infant Formula immediately and to seek medical attention if any symptoms of botulism appear in their infants. Symptoms to note include difficulty feeding, weakness, and lack of muscle tone. The only FDA-approved treatment for infant botulism is an antitoxin known as BabyBIG, which is manufactured by the CDPH and reduces hospitalization time for affected infants.

The FDA and public health officials are actively examining the remaining formula to trace the source of contamination. They recommend that anyone who has leftover product report it without discarding it, to aid in the ongoing investigation. Officials will conduct further tests in the coming weeks to gain more clarity on the situation.

As investigations proceed, the health and safety of infants remain the top priority for the CDC, FDA, and state health departments.