A significant recall of baby formula has been announced by ByHeart, following an outbreak of infant botulism affecting multiple states. The company initiated a voluntary recall of two specific batches of its Whole Nutrition Infant Formula on November 8, 2025, after receiving information from the U.S. Food and Drug Administration (FDA) regarding an ongoing investigation into the outbreak. Reports indicate that approximately 83 cases of infant botulism have been documented across the United States since August 2025, with 13 infants potentially having consumed ByHeart formula.
In a statement on its website, ByHeart reassured customers, saying, “It’s important to know that the FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product.” The company emphasized its commitment to safety, stating, “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 recall specifically targets 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 UPC code: 5004496800. Consumers can find the batch code printed on the bottom of the formula can. The affected products are sold online and at major retailers throughout the country. As of now, no other batches of ByHeart’s infant formula are implicated in this recall.
Understanding Infant Botulism
Infant botulism is a rare but serious illness caused by a toxin that impacts the nervous system. The primary culprit is the bacteria Clostridium botulinum, which can produce toxins in food, as well as in the intestines of infants and in wounds. While these bacteria typically exist in spore form and do not cause illness, under certain conditions—such as low acidity, low oxygen, and appropriate moisture levels—they can thrive and produce a potent toxin.
According to the Centers for Disease Control and Prevention (CDC), symptoms of infant botulism can include:
– Constipation
– Diminished suck and gag reflexes
– Drooping eyelids
– Flatted facial expression
– Poor feeding
– Respiratory difficulties
– Weak cry
If untreated, infant botulism can result in severe health complications and may be life-threatening.
Current Outbreak Investigation
The FDA and CDC are collaborating with various health departments, including the California Department of Public Health, to investigate the multi-state outbreak of infant botulism. As of the latest update on November 8, confirmed or suspected cases have been reported in ten states, including:
– Arizona
– California
– Illinois
– Minnesota
– New Jersey
– Oregon
– Pennsylvania
– Rhode Island
– Texas
– Washington
All 13 infants involved in the outbreak were hospitalized for treatment, but fortunately, no fatalities have been reported. Each of these infants had consumed the ByHeart formula that is now under recall.
Action for Consumers
Parents and caregivers who have purchased the recalled ByHeart formula are advised to cease using the affected products immediately. The company has stated that it will replace any discarded cans from the affected batches at no cost. If an infant exhibits symptoms associated with botulism, it is critical to seek medical attention promptly.
For further assistance, consumers can contact the FDA Consumer Complaint Coordinator or submit a report through the Voluntary MedWatch form. Additionally, ByHeart can be reached directly via email at [email protected] or by calling 1 (833) 429-4327.
As the situation develops, maintaining vigilance regarding product safety remains essential for the well-being of infants across the country.
