ByHeart has announced an expansion of its voluntary recall of infant formula amid an ongoing investigation by the U.S. Food and Drug Administration (FDA) into a potential botulism outbreak affecting infants. The move follows an earlier recall issued at the beginning of the month and reflects growing concerns over the safety of babies who consumed the company’s products.
In a press release and notice published on its website, ByHeart stated that the recall now covers all batches of ByHeart Whole Nutrition Infant Formula and Anywhere Pack across the United States. The company listed product identification numbers to help consumers determine whether their purchases are included in the recall.
According to the FDA, 15 suspected or confirmed infant botulism cases have been reported in 12 states as of Monday. All affected infants were hospitalized, though no deaths have been reported. Federal and state health agencies — including the Centers for Disease Control and Prevention (CDC) and the California Department of Public Health (CDPH) — continue to investigate the source of the infections and their potential connection to ByHeart products.
ByHeart Expands Infant Formula Recall Amid Ongoing Botulism Concerns
While laboratory tests have not detected Clostridium botulinum bacteria or toxins in unopened formula samples, health authorities believe there may be a link between certain reported cases and the consumption of ByHeart products. The company said this prompted the decision to broaden the recall “out of an abundance of caution.”
Infant botulism, though rare, is a serious illness caused by the ingestion of bacterial spores that colonize an infant’s intestines and produce toxins affecting the nervous system. Symptoms may include muscle weakness, constipation, and breathing difficulties, particularly in babies with immature digestive systems.
ByHeart emphasized that it operates under strict health oversight and tests every production batch through third-party laboratories. It also pledged full cooperation with regulators by granting unrestricted access to its facilities and unopened inventory.
ByHeart Founders Reaffirm Commitment to Child Safety as FDA Probe Widens
In a joint statement, company founders Mia Funt and Ron Belldegrun said the expanded recall was based on new information provided by the FDA regarding two additional infant cases linked to their products. “Child safety remains our top priority,” they stated, noting that the recall is meant to ensure transparency and consumer trust as investigations continue.
Health authorities are urging families who purchased the affected products to immediately stop using them and dispose of the formula safely. Parents seeking further information are encouraged to contact ByHeart’s consumer care team via email.
This recall comes amid a broader wave of food safety alerts in the U.S. this year, involving potential contamination, allergens, and labeling issues. The FDA continues to warn that the most common allergens include milk, eggs, fish, peanuts, wheat, soy, shellfish, tree nuts, and sesame.
As federal investigations continue, parents are advised to remain vigilant when purchasing baby food and formula, verify recall identification numbers, and seek prompt medical attention if their infants show concerning symptoms.