A popular baby formula brand, ByHeart, has initiated a voluntary recall of two batches of its product following a significant outbreak of infant botulism in the United States. The company announced the recall on November 8, 2025, after being informed by the U.S. Food and Drug Administration (FDA) of an ongoing investigation into the outbreak, which has reportedly involved an estimated 83 cases since August 2025.
According to the FDA, 13 of the infants affected received ByHeart formula at some point. In a statement released on their website, ByHeart emphasized that the FDA has not established a direct link between their formula and the cases of infant botulism, and no toxins have been detected in their 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 statement noted.
Details of the Recall
The recall encompasses two specific batches of the ByHeart Whole Nutrition Infant Formula:
– **Batch Code:** 251261P2, **Use by:** 01 December 2026
– **Batch Code:** 251131P2, **Use by:** 01 December 2026
Both batches share the same Universal Product Code (UPC): 5004496800. Consumers can locate the batch code on the bottom of the formula can. The affected products were available for purchase online and at major retail locations across the country. At this time, no other batches of ByHeart’s infant formula are included in the recall.
Understanding Infant Botulism
Infant botulism is a rare but serious condition caused by a toxin produced by the bacterium Clostridium botulinum, which affects the nervous system. This bacteria can thrive in food, the intestines of infants, and wounds. While the spores produced by the bacteria usually do not pose a risk, they can become dangerous under specific conditions, such as:
– Adequate moisture
– Certain temperature ranges
– Low acid levels
– Low oxygen environments
– Low salt and sugar content
Symptoms of infant botulism can include constipation, diminished reflexes, drooping eyelids, a flatted facial expression, poor feeding, respiratory difficulties, and a weak cry. If untreated, the condition can lead to severe complications.
The FDA and the Centers for Disease Control and Prevention (CDC) are now investigating the multi-state outbreak in collaboration with the California Department of Public Health and various state and local partners. As of the latest update on November 8, 2025, 13 infants with confirmed or suspected cases of botulism have been reported across 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All affected infants have been hospitalized for treatment, but no fatalities have been reported.
Consumer Guidance
Consumers who have purchased the recalled ByHeart formula are advised to cease using the product immediately and dispose of it safely. ByHeart has offered to replace any discarded cans from the affected batches at no additional cost. It is crucial for parents or guardians who notice symptoms of botulism in their infants to seek medical attention promptly.
For any adverse reactions or illnesses, individuals should contact an FDA Consumer Complaint Coordinator or submit a report through the Voluntary MedWatch form. Additionally, consumers can reach ByHeart directly at [email protected] or by calling 1 (833) 429-4327 for further assistance.
As the investigation continues, health officials urge vigilance and prompt action to ensure the safety of affected infants.
