Image courtesy FDA

The Food and Drug Administration has released additional inspection reports detailing serious sanitation and contamination concerns at ByHeart infant formula facilities, as the company’s product has been tied to at least 37 confirmed cases of infant botulism across 17 states. All affected infants have been hospitalized, and another 70 cases are under investigation.

Initial inspection documents released Nov. 26 showed repeated contamination risks, maintenance failures, and numerous consumer complaints. Newly released 2025 inspection findings highlight continued problems, including improperly stored ingredients, inadequate response to rodent activity, and insufficient monitoring after confirmed bacteria findings (Cronobacter sakazakii). Inspectors also cited poor hygiene barriers and unmonitored air-pressure systems.

Multiple Form FDA 483 reports from 2025 note failures to prevent adulteration, exclude pests, and maintain sanitary conditions. Earlier reports from 2023 and 2024 warned of aging facilities, product-quality complaints, and the potential for future issues.

At ByHeart’s Oregon plant, consumer complaints linked the formula to possible Salmonella, Campylobacter, and E. coli illnesses. The company’s Pennsylvania plant, shut down before the outbreak, previously received a 2023 warning letter.

The FDA continues investigating as the outbreak grows.