ByHeart baby formula recalled due to 10-state infant botulism outbreak
A leading producer of organic baby formula is recalling certain batches of its product after federal health authorities linked it to a widespread infant botulism outbreak across 10 states.
The U.S. Food and Drug Administration (FDA) confirmed that 13 infants have been hospitalized since August after consuming ByHeart Whole Nutrition Infant Formula. Fortunately, no fatalities have been reported.
The affected formula includes two batches with a 'use by' date of December 1st, according to the FDA's statement on Saturday (https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025?utmmedium=email&utmsource=govdelivery). The specific lot numbers are 206VABP/251261P2 and 206VABP/251131P2.
The FDA advises parents and caregivers to record the product's identifying information and dispose of it immediately. They are also working with retailers to remove all potentially affected formula from store shelves.
Infant botulism is a serious condition caused by a toxin produced by bacteria, leading to symptoms like constipation, feeding difficulties, loss of head control, and swallowing issues. In severe cases, it can result in paralysis and even death, according to the Centers for Disease Control and Prevention (https://www.cdc.gov/botulism/hcp/clinical-overview/infant-botulism.html).
The FDA warns that parents who have recently fed ByHeart formula to their children should monitor them closely, as botulism symptoms may take weeks to appear. The outbreak has been linked to cases in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
ByHeart, based in New York City, claims that government and internal tests have not detected botulism in their product. They are taking a proactive approach to remove any potential risk from the market and ensure infant safety, emphasizing that the FDA has not identified a direct link between the formula and the cases. The company also highlights that there is no historical precedent of infant formula causing infant botulism.
The FDA is currently testing leftover formula in several states and aims to determine the source of contamination and whether any other products are affected. The California Department of Public Health has separately reported an increase in infant botulism cases among ByHeart consumers since August.
ByHeart specializes in organic, grass-fed whole milk-based infant formula, which they claim is closer in composition to breast milk. Their facilities in Iowa, Pennsylvania, and Oregon supply formula to approximately 12,000 retailers. However, ByHeart accounts for less than 1% of the baby formula market in the U.S., according to the FDA.
Treatment for infant botulism involves BabyBIG, an FDA-approved 'orphan drug' containing antibodies to combat botulinum neurotoxins, as advised by the California Department of Public Health (https://www.cdph.ca.gov/Programs/cls/idld/ibtpp).
This developing story highlights the importance of thorough product testing and the potential risks associated with infant formula. As the investigation continues, parents and caregivers are urged to stay informed and take necessary precautions.
