ByHeart Infant Formula Recall Linked to Nationwide Botulism Outbreak
Parents trust that the products they feed their infants are safe, reliable, and produced under the highest possible standards. When that trust is broken, the consequences can be devastating. This is the reality facing families across the United States as federal and state health officials investigate a growing outbreak of infant botulism linked to ByHeart Whole Nutrition powdered infant formula.
According to the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) thirty-one infants from fifteen states have been sickened as of November 19, 2025. All infants consumed ByHeart Whole Nutrition powdered formula before developing symptoms and every reported child required hospitalization. While no deaths have occurred, the severity of infant botulism makes this an urgent public health issue. The outbreak has resulted in a nationwide recall of all ByHeart infant formula products, including cans and single serve packet sticks. Despite this recall, federal and state regulators have confirmed that recalled items have continued to appear on store shelves in multiple states creating additional risk for unsuspecting families.
Infant botulism is a rare but serious illness caused by Clostridium botulinum, a bacterium that produces a potent neurotoxin. Infants under twelve months are particularly vulnerable because their digestive systems are not yet mature enough to prevent the growth of these spores. Symptoms may appear gradually and can include constipation, difficulty feeding, loss of head control, decreased facial expression, and overall weakness. In severe cases infants may require intensive medical support. Experts warn that symptoms can take up to thirty days to appear which is why ongoing monitoring is essential for infants who consumed ByHeart products.
Laboratory findings from federal and state agencies have revealed troubling information. The California Department of Public Health identified botulinum neurotoxin type A in an opened can of ByHeart formula that had been fed to an affected infant. Additional testing confirmed the presence of Clostridium botulinum in the product. ByHeart also conducted its own testing on unopened formula samples stored at its facility. Results showed five out of the thirty-six samples tested positive for the bacteria. Since theresults spanned three different lots, the company to announced that it cannot rule out contamination in any of its products.
This raises concerns about the manufacturing oversight and safety protocols in place at the time these products were created. Detecting bacterial contamination in powdered formula is challenging because contamination may exist in small clusters rather than throughout an entire batch. A negative test result does not guarantee product safety. The FDA continuing its investigation and has collected unopened formula samples from ByHeart facilities for additional analysis.
While ByHeart issued a full recall on November 11, 2025, enforcement has proven difficult. Reports indicated that the recalled formula was still being sold at major retailers, including Walmart, Target, and Kroger as well as grocery chains such as Safeway, Jewel-Osco, and Shaw’s. Online marketplaces have also been a source of the recalled product.
For families who purchased ByHeart formula, the FDA recommends immediate steps to reduce risk. Caregivers should stop using any ByHeart Whole Nutrition infant formula regardless of lot number size or packaging format. Leftover formula should be labeled as not for use and stored safely for at least one month. State health departments may request samples if an infant becomes ill. Surfaces that contacted the product should be washed with hot soapy water and caregivers should watch closely for symptoms of infant botulism.
At Goldberg, Persky & White, P.C., we understand how frightening and overwhelming situations like this can be, especially when the health of a child is at stake.
Our firm has decades of experience representing families harmed by unsafe products and negligent manufacturers. We work to ensure that companies are held accountable when their failures cause injury or put lives at risk.
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