Infant Formula Maker Linked to Botulism Outbreak Had Prior Safety Issues

Inspection uncovers serious violations at Pennsylvania plant

Federal inspectors ordered the immediate shutdown of the ByHeart infant‑formula plant in York County, Pennsylvania after a routine inspection revealed multiple health‑code violations that could jeopardize the safety of its products.

What officials found

The inspection team documented extensive mold growth on walls and equipment in the production area, a leaking roof that allowed water to pool near processing lines, and the presence of more than 2,500 dead insects scattered across the floor. Such conditions are considered “unsanitary” under FDA regulations and raise the risk of bacterial contamination.

Background of the facility

This is not the first time the ByHeart plant has attracted regulatory attention. Earlier reports indicated that the company received warning letters for inadequate sanitation practices and for failing to implement corrective actions after previous inspections.

Connection to the botulism outbreak

Public health investigators have linked a recent infant‑botulism outbreak to formula produced at the same facility. While a definitive causal link is still under review, the discovery of mold and insect debris has intensified scrutiny of the plant’s overall hygiene and quality‑control procedures.

Company response

ByHeart issued a statement saying it is “fully cooperating with federal authorities” and that it is “committed to addressing all deficiencies identified during the inspection.” The company also pledged to conduct a comprehensive cleaning and remediation effort before seeking permission to resume operations.

Regulatory outlook

The Food and Drug Administration (FDA) has indicated that the plant will remain closed until it can demonstrate compliance with all applicable safety standards. Until then, the agency warns consumers to verify the source of any infant formula they purchase and to follow recall notices closely.