ByHeart, a Pennsylvania-based baby formula company once lauded for its innovation and rapid growth, now finds itself at the center of a nationwide infant botulism outbreak that has sickened dozens of babies and prompted urgent recalls, federal investigations, and a wave of scrutiny over food safety practices. The company’s Berks County plant, which had received millions in promised state support and visits from prominent officials, halted production in 2023 after federal inspectors found what they described as “significant violations”—including mold and thousands of dead insects in food production areas.
According to the Food and Drug Administration (FDA), at least 37 confirmed or suspected cases of infant botulism have been linked to ByHeart formula since August 2025, with the most recent case reported on November 19. The outbreak has rattled parents, caregivers, and health officials, especially as ByHeart products represent only about 1% of the U.S. infant formula market but are disproportionately implicated in the illnesses. “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak,” the FDA said, highlighting the seriousness of the situation.
The company moved swiftly to recall two lots of its formula in early November 2025, before expanding the recall to all products nationwide on November 11. Yet, according to state officials and the FDA, some ByHeart formula remained on store shelves even after the recall was announced—raising concerns about the effectiveness of recall enforcement and communication. In a statement published on its website, ByHeart acknowledged the gravity of the situation: “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”
Laboratory tests of 36 samples from three different lots of ByHeart formula found that five samples contained the type of bacteria that can cause botulism, a rare but potentially deadly illness. The company’s own admission that it could not guarantee the safety of any product batch underscored the urgency for parents and caregivers to stop feeding ByHeart formula to infants immediately. Health officials have warned that symptoms of infant botulism—such as constipation, difficulty feeding, drooping eyelids, a flat facial expression, and weakness in the limbs and head—can take up to 30 days to appear. The illness is a medical emergency requiring prompt treatment, often with an intravenous medication known as BabyBIG. Since August 1, at least 107 babies nationwide have received this treatment, a striking number given that fewer than 200 infants are typically treated for botulism in an entire year.
The outbreak’s timeline reveals a pattern of mounting safety concerns at ByHeart’s Berks County facility. ByHeart acquired the plant in 2019, registering it with the FDA in April 2022. That summer, the company discovered the bacterium cronobacter sakazakii—another dangerous pathogen—in both the processing area and a can of finished formula. ByHeart subsequently recalled five batches of formula in December 2022 due to the potential for cross-contamination. However, the company insisted at the time that “recall is not related to ByHeart’s own manufacturing facility in Reading, PA in any way” and that the facility continued to operate around the clock.
Problems worsened in August 2023, when the FDA found what it called “significant violations” at the Berks County plant. Inspectors later reported finding mold in a clean water tank and thousands of dead insects in a food production area, classifying the inspection at the agency’s highest tier of concern. ByHeart responded by initiating a series of upgrades at the plant, particularly after acquiring a second facility in another state. “These improvements are part of our commitment to strengthen quality and safety systems,” the company stated, adding that it had provided the FDA with ten detailed updates on corrective actions and progress.
Despite the turmoil, ByHeart’s ties to Pennsylvania’s government and economic development efforts have remained strong. The state awarded the company $18 million in grants through the Redevelopment Assistance Capital Program, including $5 million as recently as November 2024, to support facility upgrades and expansion. However, the Shapiro administration confirmed that none of this money has been paid out, as the grants are reimbursable and require proof of completed construction before funds are released. “The Shapiro Administration takes seriously any claims of violations that compromise the health and safety of our food manufacturing facilities,” a spokesperson for Gov. Josh Shapiro said. “We will continue to prioritize the safety and wellness of all Pennsylvanians.”
ByHeart is currently seeking an additional $15 million through the same grant program to build an “all-new, state-of-the-art facility.” The company has consistently praised the state’s partnership, stating, “The Commonwealth has been a tremendous partner since day one, and we are grateful for their support.” Over the years, the state’s Redevelopment Assistance Capital Program has faced criticism for its lack of transparency and minimal job creation, with audits calling for greater oversight over the hundreds of millions of dollars distributed through the initiative.
The company’s leadership has also been closely connected to Pennsylvania’s civic and business circles. ByHeart was co-founded by siblings Mia Funt and Ron Belldegrun, both University of Pennsylvania graduates. In June 2024, Belldegrun joined the board of Team PA, a Harrisburg-based nonprofit focused on economic development that manages funds benefiting the governor’s office.
Federal and state officials have kept a close eye on ByHeart’s operations. U.S. Rep. Chrissy Houlahan, whose district includes the Berks County facility, toured the plant in 2024 and described it as “undergoing exciting renovations to expand capacity and increase production safety.” Pennsylvania’s Secretary of Agriculture Russell Redding and First Lady Lori Shapiro toured the plant in late October 2025. At the federal level, U.S. Rep. Rosa DeLauro, chair of the Congressional Food Safety Caucus, sent a letter to the FDA commissioner in November 2025 requesting all inspection records for ByHeart’s three facilities—located in Berks County, Allerton, Iowa, and Portland, Oregon.
While some Pennsylvania officials have declined to comment publicly, Houlahan told reporters in Washington, D.C., “My understanding is that they’re doing everything that they’re supposed to be doing to make sure that’s addressed,” though she noted she hasn’t been in direct communication with the company recently.
For now, parents and caregivers are urged to remain vigilant. The FDA and state health departments advise anyone who purchased ByHeart formula on or after August 1 to stop using it immediately and monitor infants for symptoms. The company is offering full refunds to affected consumers, expanding its previous policy. To report an illness tied to the outbreak, families can contact the FDA’s consumer complaint coordinator or fill out an online MedWatch form.
As ByHeart works with the FDA and Centers for Disease Control and Prevention on a comprehensive investigation, the episode serves as a sobering reminder of the critical importance of food safety oversight and transparent communication in protecting the nation’s most vulnerable.
