The ByHeart infant formula company has taken a firm stand for the safety of infants. It has announced a recall for all formulas sold not only in the U.S but nationwide regardless of its form – either in a can or single-serve pouches.
Earlier, ByHeart had sensed a potential concern and issued a partial recall service after a multistate outbreak of 13 infant botulism cases were reported by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) in tie-up with the California Department of Public Health (CDPH).
An addition of two cases of infant botulism was confirmed on November 11, affecting infants who had consumed ByHeart formula. This alarming detection compelled ByHeart to issue a recall on all of its infant formula.
The recall has affected at least 10 states. The reported cases were identified in babies who have reportedly consumed ByHeart powdered formula sold in the period of August 2025 to November 2025.
The Infant Botulism Treatment and Prevention Program run by the CDPH had conducted initial testing of a ByHeart formula sample connected to one of the cases. The department discovered the presence of the bacteria that can induce botulism.
Addressing its customers, ByHeart cited in an Instagram post on November 11 that they are concerned about the health and well-being of its consumers. The post also highlighted that neither them nor FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula.
Infant botulism is a serious ailment and can lead to paralysis or in rare cases, even death. This can be caused due to entering toxins into a baby's intestines leading to weakened muscles.
The specific cause is still under thorough examination, and the results along with more information will be released within the coming weeks.
The recall on all ByHeart products was largely driven by a virtual meeting with the FDA. The FDA informed ByHeart about additional cases of infant botulism which were linked to infants who had consumed ByHeart formula.
The co-founders of ByHeart, Mia Funt & Ron Belldegrun expressed their grief about the incident in a statement released on November 11. The statement emphasized that the primary concern of ByHeart was baby safety.
Same day, ByHeart advised its thousands of consumers via a release on their website that those who have the recalled formula at home should stop using it immediately. Consumers were also advised to record the batch number which can be found at the bottom of the can and dispose of it safely.
ByHeart also ensured their customers that they are readily available for any queries or concerns via email or their 24/7 hotline.
ByHeart expressed its understanding that the recall may be financially challenging for families. In an attempt to support customers through this transition, ByHeart has partnered with Nara Organics, offering affected customers 20% off their first order along with free express shipping using a specific code.
Considering that ByHeart Whole Nutrition Infant Formula only constitutes about 1% of all infant formula sales in the U.S., the FDA reported that there will be no shortage of infant formula for parents and caregivers due to this recall.
ByHeart remains committed to the safety of its consumers and has recalled all cans and single-serve packs of its signature baby formula. The recall was prompted after 15 infants diagnosed with infant botulism were confirmed to have consumed ByHeart formula.
ByHeart is readily available to address queries or concerns of its consumers, and promises a smooth process for those requiring a refund on the recalled formula.
Awareness must be created among the public about the symptoms of the rare but potentially dangerous condition of infant botulism. Infant botulism can occur in babies after they consume Clostridium botulinum spores. These spores can be found in soil and water, and in some foods like honey. These spores can negatively affect a baby's intestinal tract and produce neurotoxins in the baby's gut.
Some of the primary symptoms of infant botulism include constipation, poor feeding, droopy eyelids, sluggish pupils, low muscle tone, difficulty in sucking and swallowing, weak cry, trouble breathing or respiratory distress, and general weakness throughout the body. If early signs are observed, it is advisable to seek medical treatment immediately.