ByHeart Baby Formula Linked to Alarming Botulism Outbreak

Mon Nov 10 2025 01:24:03 GMT+0200 (Eastern European Standard Time)

Health officials warn parents about potential risks as California tests show bacteria linked to botulism in ByHeart baby formula, which has already caused illness in multiple infants across the country.

California health officials have identified a type of bacteria in ByHeart Whole Nutrition Infant Formula that is linked to a botulism outbreak affecting 13 infants across 10 states. The company has recalled two lots of the formula, while investigations continue as experts warn of the seriousness of infant botulism, which can lead to severe health issues. Authorities emphasize the need to monitor infant formula ingredients as part of ongoing safety reviews.

Preliminary tests indicate that ByHeart baby formula contains bacteria linked to a serious botulism outbreak that has sickened at least 13 infants across 10 states, according to California health officials. There have been no reported fatalities, but the outbreak has raised significant concerns regarding infant safety.

“Parents should refrain from using this product immediately,” stated the California Department of Public Health. ByHeart has issued a recall for two lots of their Whole Nutrition Infant Formula, which is being scrutinized as investigations continue.

Understanding the Outbreak

All affected infants, aged from 2 weeks to 5 months, were hospitalized after consuming the contaminated formula. The Centers for Disease Control and Prevention (CDC) reports cases from Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington state.

California health officials are awaiting further test results to confirm the presence of the bacteria associated with botulism. Authorities are taking the situation seriously as investigations into potential causes expand.

Infant Botulism Overview

Typically, infant botulism affects fewer than 200 babies annually in the U.S., caused by bacteria producing toxins in the digestive tract. Infants are most at risk, particularly from environmental spores found in soil, dust, or contaminated food such as honey.

Symptoms, which can take weeks to develop, include poor feeding, loss of head control, and a 'floppy' appearance. Treatment options include an IV medication known as BabyBIG, which has been administered to all affected children linked to this outbreak.

Impact and Future Challenges

Despite the seriousness of this situation, health experts assure that there is no immediate risk of shortage in formula supplies, as ByHeart only accounts for about 1% of the market share in the U.S. The more critical analysis is geared toward the full investigation into the ingredients and safety mechanisms of formulas across the board.

This incident raises broader questions about regulatory measures for infant food products, especially as federal health officials plan to conduct a comprehensive review of the U.S. food supply.