Congresswoman Presses FDA to Release ByHeart Inspection Records Amid Infant Botulism Outbreak
U.S. Representative Rosa DeLauro (D-Connecticut), Chair of the Congressional Food Safety Caucus, has written a letter to U.S. Food and Drug Administration (FDA) Commissioner Marty Makary, M.D., urging the agency to release inspection documents of ByHeart Inc. production facilities.
ByHeart formula has been implicated in an ongoing infant botulism outbreak in which at least 23 babies across 13 states have fallen ill.
Since the outbreak investigation commenced, FDA inspection reports and warning letters have come to light showing a history of food safety and hygiene violations at ByHeart production facilities. For example, issues like mold, dead insects, and reoccurring roof leaks at the company’s Reading, Pennsylvania facility caused the plant to be shut down earlier in 2023. Additionally, the firm received a warning letter from FDA in 2023 after a batch of finished product tested positive for Cronobacter sakazakii, prompting an investigation of the production facility. Not only did FDA find a roof leak in a production area, and lapses in Standard Operating Procedures (SOPs) and cleaning and sanitation verification activities that could allow microbiological contamination to occur, but the agency also reprimanded ByHeart for failing to conduct a comprehensive root cause analysis of the C. sakazakii contamination.
In her letter, Rep. DeLauro requests that FDA release inspection records from all three of ByHeart’s plants in Pennsylvania, Iowa, and Oregon by no later than Wednesday, November 19, calling for transparency around FDA’s investigation practices. “There is no excuse for inaction when children’s safety is on the line,” she said.
Update, November 19, 2025: The number of infant botulism cases linked to consumption of ByHeart formula has grown to 31 across 15 states.
Update, November 26, 2025: ByHeart Inc. has found Clostridium botulinum Type A in five of 36 samples across three lots. “Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” said the company.
As of November 26, the number of infant botulism cases in the associated outbreak has grown to 37 across 17 states. Additionally, FDA has released ByHeart facility inspection reports from as early as 2022 showing a history of food safety breaches.
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Update, December 3, 2025: A total of 39 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported across 18 states. All 39 infants were hospitalized; no deaths have been reported.
Update, December 16, 2025: As of December 10, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported across 19 states. All 51 infants were hospitalized; no deaths have been reported.
On December 15, FDA issued an open letter to all food industry stakeholders describing firms’ legal obligations in the case of a food safety incident and outlining best practices for effective recalls. Separately, FDA sent warning letters to four major retailers—Target, Walmart, Kroger, and Albertsons—for failing to remove recalled ByHeart infant formula from store shelves.
