Inspectors found multiple problems at ByHeart infant formula production plants

The company linked to an outbreak of infant botulism closed one of its manufacturing plant this year after federal inspectors found numerous safety violations, according to a story by the New York Times.

ByHeart Inc. is implicated in the outbreak because a sample of its powdered infant formula collected from a California patient’s home tested positive for the same strain of botulism that is making babies sick.

The company has recalled all of its formula because of the outbreak, which has sickened a confirmed 15 babies. All 15 babies were fed ByHeart formula. The company was notified in recent weeks of an uptick of infant botulism cases of 84 patients since August.

Dr. Erica Pan, California’s top public health officer, said the department noticed an uptick of reports beginning on Aug. 1. Of about 84 infants treated for botulism, she said, about 36 were fed formula, including 15 who ingested ByHeart formula.

Pan told the Times that the number of infected infants who had consumed ByHeart formula jumped out at her, because the company’s sales account only for about 1 percent of the national formula market.

“So that was a very disproportionate, very concerning signal of what’s going on here,” Dr. Pan told the Times.

The Centers for Disease Control and Prevention reports that there are usually about 130 to 180 cases of infant botulism reported annually.

In 2023 the FDA sent a warning letter to ByHeart after finding “serious” food safety violations at one of its production facilities.

The FDA is now investigating ByHeart facilities in Allerton, IA, and Portland, OR, which produced the recalled formula, according to the Times story. Inspectors are trying to determine if there is a link between the processing centers and the outbreak patients.

“The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions,” the company said in a statement.

In December 2023 FDA inspectors and found problems at the ByHeart production facility in Pennsylvania, according to an agency inspection report provided by Redica Systems, a company that collects and sells the reports, according to the Times.

The Pennsylvania facility had a leaking roof and inspectors observed flies overhead in an area of formula production. In the same area, the inspector observed more than 2,500 dead bugs. 

FDA inspectors also noted that the plant violated its own rules for maintaining temperatures needed to eliminate bacteria from the formula before it was shipped for packaging, the report said. Variations in temperature should have prompted a report to a supervisor, but no notification occurred, and the formula went out to customers.

Ron Belldegrun, ByHeart’s chief executive, founded the company with Mia Funt, his sister, after a career in venture capital and hedge fund management. Funt, the company’s president, helped form ByHeart after working as a marketing and business development executive.

ByHeart has grown rapidly, raising more than $70 million this spring from investors in a deal that valued the company at more than $900 million, according to the Times.

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Source: https://www.foodsafetynews.com/2025/11/inspectors-found-multiple-problems-at-byheart-infant-formula-production-plants/