ByHeart has announced a voluntary recall of two batches of its Whole Nutrition Infant Formula due to an ongoing outbreak of infant botulism affecting multiple states. The recall was initiated on November 8, 2025, following notification from the U.S. Food and Drug Administration (FDA) regarding the outbreak. Since August 2025, approximately 83 cases of infant botulism have been reported in the United States, with 13 infants who consumed ByHeart formula among those affected.
In a statement posted on its website, ByHeart emphasized that the FDA has not identified a direct connection between its formula and infant botulism, nor have any toxins been detected in their products. The company stated, “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.”
Details of the Recall
The affected batches of ByHeart Whole Nutrition Infant Formula are as follows:
– **Batch Code:** 251261P2, **Use by:** 01 December 2026
– **Batch Code:** 251131P2, **Use by:** 01 December 2026
Both batches carry the same UPC code: 5004496800, which can be found on the bottom of the product can. The formula is sold both online and at major retailers across the country. Currently, no other batches of ByHeart’s infant formula have been implicated in this recall.
Understanding Infant Botulism
Infant botulism is a serious and rare illness caused by a toxin that affects the body’s nervous system. The condition is primarily the result of the bacteria Clostridium botulinum, which can produce toxins in food, the intestines of infants, and in wounds. Notably, the bacteria create spores that can survive extreme conditions. While these spores typically do not cause illness, under certain circumstances, they can grow and release a potent toxin.
Conditions that facilitate this growth include the presence of moisture, specific temperature ranges, low acidity, and low oxygen levels. The Centers for Disease Control and Prevention (CDC) warns that infant botulism can lead to serious complications, including bulbar palsies and flaccid paralysis. Symptoms to watch for include:
– Constipation
– Weak or absent reflexes for sucking and gagging
– Drooping eyelids
– Reduced facial expression
– Difficulty feeding
– Breathing problems
If left untreated, infant botulism can be life-threatening.
Extent of the Outbreak
The FDA and CDC are investigating the multi-state outbreak in collaboration with the California Department of Public Health and local health authorities. As of the latest update on November 8, 13 infants with confirmed or suspected cases have been reported across ten states, including:
– Arizona
– California
– Illinois
– Minnesota
– New Jersey
– Oregon
– Pennsylvania
– Rhode Island
– Texas
– Washington
All infants involved have been hospitalized for treatment, but thankfully, no fatalities have been reported. It is noteworthy that all 13 infants had consumed the ByHeart formula prior to their hospitalization.
Next Steps for Consumers
Consumers who purchased the recalled ByHeart infant formula should cease use of the affected products immediately and dispose of them. ByHeart has committed to replacing any discarded cans from the impacted batches at no additional cost. Parents and caregivers who notice any symptoms of infant botulism in their children are urged to contact their healthcare provider without delay.
In case of any adverse reactions or illnesses, consumers should report the incident to an FDA Consumer Complaint Coordinator or submit a Voluntary MedWatch form. For further assistance, ByHeart can be reached directly at [email protected] or by calling 1 (833) 429-4327.
This recall serves as a reminder of the importance of vigilance when it comes to infant nutrition and health.
