A significant recall has occurred concerning a popular baby formula brand, ByHeart, due to a nationwide investigation into infant botulism cases. On November 8, 2025, ByHeart voluntarily recalled two batches of its Whole Nutrition Infant Formula after receiving a notification from the U.S. Food and Drug Administration (FDA). The FDA alerted the company about an ongoing investigation into approximately 83 reported cases of infant botulism across the United States since August 2025, with 13 infants having consumed ByHeart formula at some point.
In its statement, ByHeart emphasized that the FDA has not found direct evidence linking its formula to the reported cases of infant botulism, nor have any related toxins been detected in its products. “Still, we decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart—including our own—will always come first,” the company stated on its website.
Details of the Recall
The recall includes the following batches of ByHeart Whole Nutrition Infant Formula:
– **Batch Code:** 251261P2, **Use by:** December 1, 2026
– **Batch Code:** 251131P2, **Use by:** December 1, 2026
Both batches have the same UPC code: 5004496800, which can be found on the bottom of the formula cans. The affected products are available online and at major retailers nationwide. Currently, no other batches of ByHeart’s infant formula have been implicated in this recall.
Understanding Infant Botulism
Infant botulism is a rare but serious illness caused by a toxin produced by the bacterium Clostridium botulinum. According to the Centers for Disease Control and Prevention (CDC), the toxin affects the nervous system and can arise from spores present in food, infant intestines, or wounds. While these spores typically do not cause illness, they can thrive under certain conditions, leading to toxin production.
Factors that allow the bacteria to thrive include:
– Sufficient moisture
– Specific temperature ranges
– Low acidity
– Low oxygen or anaerobic environments
– Low salt and sugar levels
Symptoms of infant botulism can manifest as constipation, diminished suck and gag reflexes, drooping eyelids, a flat facial expression, poor feeding, respiratory difficulties, and a weak cry. If untreated, the condition can become life-threatening.
Geographical Spread of the Outbreak
The FDA and CDC are collaborating with the California Department of Public Health and various state and local partners to investigate the multi-state outbreak of infant botulism. As of the November 8 update, 13 infants have been confirmed or suspected to have botulism across ten states:
– Arizona
– California
– Illinois
– Minnesota
– New Jersey
– Oregon
– Pennsylvania
– Rhode Island
– Texas
– Washington
All affected infants, aged between 16 and 157 days, were hospitalized for treatment, and fortunately, no fatalities have been reported.
Consumer Guidance
Parents and caregivers who have purchased the affected ByHeart infant formula are advised to stop using the product immediately and dispose of it. ByHeart has committed to replacing any discarded cans from the affected batches at no additional cost.
If an infant exhibits symptoms related to botulism, it is crucial to contact a healthcare provider without delay. In cases of illness or adverse reactions, consumers should either call an FDA Consumer Complaint Coordinator or fill out a Voluntary MedWatch form. For further assistance, ByHeart can be reached at [email protected] or by calling 1 (833) 429-4327.
As this situation develops, ByHeart and health authorities continue to prioritize the safety of infants and the integrity of their products.
