Preliminary tests conducted by California health officials have indicated that ByHeart baby formula contains the type of bacteria known to produce the toxin linked to a recent botulism outbreak. This outbreak has affected at least 13 infants across 10 states, though no deaths have been reported. Following these findings, the California Department of Public Health issued a strong recommendation on Saturday, urging consumers to immediately cease using the product if they are in possession of it. Further testing of ByHeart Whole Nutrition Infant Formula is ongoing as state and federal health officials continue their investigation into the outbreak, which began in mid-August. In response, the New York-based company initiated a recall of two specific lots of its powdered product over the weekend.

The infant botulism outbreak has affected babies aged between 2 weeks and 5 months since August. According to the U.S. Centers for Disease Control and Prevention (CDC), all affected infants were hospitalized after consuming the ByHeart powdered formula. Cases have been identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. ByHeart officials have agreed to recall two lots of their Whole Nutrition Infant Formula, specifically those with a best-by date of December 2026, as confirmed by the U.S. Food and Drug Administration (FDA).

The formula tested by California health officials, which was fed to an infant who became ill, showed results suggesting the presence of botulism toxin-producing bacteria. While the company acknowledges the need for more testing to confirm the presence of the specific botulism-causing bacteria, they noted that many types of bacteria from this large family are naturally occurring and harmless. They stated on Sunday that they are taking the situation “very seriously.”

Infant botulism typically affects fewer than 200 babies in the U.S. annually and is caused by bacteria that produce toxins in the large intestine. The bacterium spreads through hardy spores found in the environment, such as dust, dirt, or water, and can also be contracted by consuming contaminated honey. Infants under the age of one are particularly susceptible to this serious illness, which can lead to paralysis. Symptoms, which can take weeks to manifest, include poor feeding, loss of head control, drooping eyelids, flat facial expression, a “floppy” sensation, and difficulties with swallowing or breathing.

Dr. Steven Abrams, a nutrition expert at the University of Texas, noted that there have been no previously confirmed infant botulism outbreaks linked to powdered formula, describing such an occurrence as “extremely rare.”

The standard treatment for infant botulism is an intravenous medication called BabyBIG, which is derived from the pooled blood plasma of adults immunized against botulism. This product, developed by California’s Infant Botulism Treatment and Prevention Program, is the sole source worldwide. BabyBIG helps to reduce the severity of the illness and shorten hospital stays for affected infants. Due to the potential impact on respiratory function, infants with botulism often require ventilation. The CDC confirmed that all children affected in the ByHeart outbreak have received this vital medication.

ByHeart, founded in 2016, holds an estimated 1% share of national formula sales, distributing its products through its website and retail stores across the country. This incident is not expected to cause infant formula shortages, a stark contrast to the crisis in 2022 when formula produced by Abbott was linked to infant deaths and illnesses due to a different type of germ. The closure of Abbott’s Michigan plant, a major manufacturer, led to widespread formula shortages.

It is notable that ByHeart itself recalled five batches of infant formula in 2022 after a sample at its packaging plant tested positive for Cronobacter sakazakii, the same germ involved in the Abbott crisis. Furthermore, in 2023, the FDA issued a warning letter to ByHeart, highlighting “areas that still require corrective actions.”

Federal health officials have committed to overhauling the U.S. food supply system and are now intensely scrutinizing infant formula. Health Secretary Robert F. Kennedy Jr. has directed the FDA to review the nutrients and other ingredients in infant formula, an initiative dubbed “Operation Stork Speed.” This marks the first comprehensive examination of formula ingredients since 1998, with the FDA currently gathering feedback from industry, health experts, and the public to determine the next steps.