A popular baby formula brand, ByHeart, is recalling two batches of its product following a multi-state outbreak of infant botulism. On November 8, 2025, the company announced a voluntary recall after the U.S. Food and Drug Administration (FDA) alerted them to an ongoing investigation into the outbreak. Since August 2025, approximately 83 cases of infant botulism have been reported across the United States, with 13 of those infants having consumed ByHeart formula.
In a statement posted on its website, ByHeart emphasized that the FDA has not found any direct link between their formula and the occurrence of infant botulism. The company stated, “No related toxins have been found in any ByHeart product.” Nonetheless, they chose to initiate the recall to eliminate any potential risk and prioritize the safety of their consumers.
Details of the Recall
The recall specifically affects two 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 share the same Universal Product Code (UPC): 5004496800. Consumers can find the batch code printed on the bottom of the formula can. These products are sold online and at major retailers throughout the United States. At present, no additional batches of ByHeart formula have been implicated in the recall.
Understanding Infant Botulism
Infant botulism is a severe illness caused by a toxin that affects the body’s nerves. According to the Centers for Disease Control and Prevention (CDC), the bacteria responsible for this illness, Clostridium botulinum, can produce toxins in food, within the intestines of infants, and in wounds. The bacteria form spores that enable them to survive in extreme conditions, and while these spores are typically harmless, they can produce toxins under specific circumstances. These include the presence of moisture, a particular temperature range, low acidity, and low or no oxygen.
Symptoms of infant botulism can include constipation, diminished reflexes, drooping eyelids, a flat facial expression, poor feeding, respiratory difficulties, and a weak cry. If left untreated, this condition can be life-threatening.
Current Outbreak Status
The outbreak is being investigated by the FDA and CDC in partnership with the California Department of Public Health and other local health authorities. As of the latest update on November 8, 2025, 13 infants with confirmed or suspected cases of infant botulism have been identified in the following states:
– Arizona
– California
– Illinois
– Minnesota
– New Jersey
– Oregon
– Pennsylvania
– Rhode Island
– Texas
– Washington
All affected infants were hospitalized for treatment, but fortunately, no fatalities have been reported. Each of the 13 infants had consumed the recalled ByHeart formula.
What Consumers Should Do
Consumers who 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 impacted batches at no cost to consumers.
If an infant exhibits symptoms related to botulism, it is crucial for parents or caregivers to contact a healthcare provider without delay. In case of any adverse reactions or illnesses, consumers are encouraged to reach out to an FDA Consumer Complaint Coordinator or complete a Voluntary MedWatch form. Additionally, ByHeart can be contacted directly via email at [email protected] or by phone at 1 (833) 429 — 4327.
This recall serves as a reminder of the importance of food safety, particularly regarding products designed for vulnerable populations such as infants.
