READING — The baby formula company whose products have been linked to a botulism outbreak that has sickened at least 23 infants stopped production at its Pennsylvania plant in 2023.
In August of that year, the FDA said it had found “significant violations” at ByHeart’s Berks County plant. Inspectors say they later found mold and thousands of dead bugs there.
The company’s representatives have appeared alongside top Pennsylvania officials, including former Gov. Tom Wolf and Secretary of Agriculture Russell Redding, several times.
Last year, U.S. Rep. Chrissy Houlahan (D., Pa.) toured the Berks County facility in her district, which she said was “undergoing exciting renovations to expand capacity and increase production safety.” Redding toured the plant in late October of this year alongside Pennsylvania First Lady Lori Shapiro.
The state has also awarded the company $18 million in grants through the Redevelopment Assistance Capital Program, including $5 million in November 2024. However, the Shapiro administration says none of that money has been paid out.
"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 in response to detailed questions. “We will continue to prioritize the safety and wellness of all Pennsylvanians."
Here’s what to know about the outbreak, the Berks facility, and what happens next:
Why did ByHeart recall its baby formula?
ByHeart issued a recall of two lots of its formula in early November before expanding it to all products.
The Infant Botulism Treatment and Prevention Program, run by California’s health department, says 84 infants nationwide were treated for botulism between Aug. 1 and Nov. 10. Thirty-six had been exposed to infant formula; of that total, 15 had consumed a ByHeart product.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA says.
In a statement to Spotlight PA, the company said it expresses “our deepest sympathy to the families currently impacted by the cases of infant botulism.”
“Our number one priority is infant health, which is why we have paused manufacturing and are working with CDC and FDA on a comprehensive investigation."
What is the history of ByHeart’s Berks County facility?
ByHeart acquired the Berks County facility in 2019 and “announced the FDA registration” of its plant in April 2022, according to a news release from the time.
Federal inspectors identified safety issues there in recent years. In a 2023 letter, the FDA said it found “significant violations” at the Berks facility, as first reported by the New York Times.
“In July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant,” The Times reported. “When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.”
ByHeart voluntarily recalled five batches of formula in December 2022 because of the “potential for cross-contamination” with the bacteria.
“Recall is not related to ByHeart’s own manufacturing facility in Reading, PA in any way,” the company said in the announcement. “Facility continues to run 24/7; re-stock expected in January.”
In late 2023, inspectors found mold in a clean water tank and thousands of dead insects “in a food production area,” according to The Times: “The [FDA] classified the inspection at its highest tier of concern.”
In a statement, ByHeart said it “began a process of upgrades” at the Berks County plant after acquiring a second facility in another state.
“These improvements are part of our commitment to strengthen quality and safety systems,” the company said. “We have provided the FDA with ten detailed updates on corrective actions and progress. This is part of the continuous process that is inherent with regulatory oversight of manufacturing.”
How has Pennsylvania supported ByHeart?
Officials, including Redding, Houlahan, and state Sen. Judy Schwank (D., Berks), have touted the state’s investment in the company and its Exeter Township facility through the Redevelopment Assistance Capital Program.
As part of the 2021 round of funding, the state awarded ByHeart $10 million to “add a canning line and end-use packaging and dry blending to the facility to become an end-to-end infant formula manufacturer.”
"ByHeart is providing wholesome, nutritious formula for our youngest Pennsylvanians," Redding said at a 2022 event celebrating the investment. "We are proud to support companies like ByHeart that embody the entrepreneurial spirit and innovation of Pennsylvania agriculture.”
Schwank touted the most recent award in November 2024 in a news release.
While the legislature authorizes how much will be spent annually through the Redevelopment Assistance Capital Program, the governor has final approval over who gets a grant.
Over the years, the program has been criticized for its lack of openness and transparency, disproportionate funding to certain communities, and minimal job creation. State audits have called for increased oversight of the process and the hundreds of millions of dollars doled out through the program.
The Shapiro administration said that none of the $18 million awarded to ByHeart has been paid out.
Such grants are reimbursable and only paid out when a grantee makes a request. “A Payment Request must include paid construction costs before any other items will be reimbursed,” according to a state website. “Therefore, if construction has not started, the Commonwealth will not reimburse on acquisition, permits, or interest costs.”
Currently, ByHeart is seeking an additional $15 million through the grant program to build an “all-new, state-of-the-art facility.”
“The Commonwealth has been a tremendous partner since day one, and we are grateful for their support,” the company said in a statement.
How are Pennsylvania officials responding to the outbreak?
Schwank’s office declined to comment for this article. State Rep. Mark Gillen, a Republican who also represents the area where the facility is located, did not return a request for comment.
At the federal level, U.S. Rep. Rosa DeLauro (D., Conn.) sent a letter to FDA Commissioner Marty Makary requesting all inspection records for ByHeart’s three facilities: in Berks County; Allerton, Iowa; and Portland, Oregon. DeLauro chairs the Congressional Food Safety Caucus. The letter requested the information by Wednesday.
A spokesperson for Houlahan, the member of Congress who represents the area, did not return a request for comment about DeLauro’s letter or the New York Times’ article.
In a brief exchange in Washington, D.C., Houlahan told a reporter for NOTUS and Spotlight PA on Monday that she was aware of the safety allegations.
“My understanding is that they're doing everything that they're supposed to be doing to make sure that's addressed,” she said, adding that she hasn’t been in communication with the company.
Does ByHeart have other Pennsylvania ties?
ByHeart was co-founded by Mia Funt and Ron Belldegrun, who are siblings. They both graduated from the University of Pennsylvania, according to a 2022 article from The Inquirer.
In June 2024, Team PA — a Harrisburg-based nonprofit that bills itself as a public-private partnership to bolster Pennsylvania's economic development — named Belldegrun as a board member.
The nonprofit manages several funds that benefit Pennsylvania's governor or his office. One of those funds is called the Pennsylvania Growth Partnership, which accepts donations that are used to promote the governor (and by extension, Pennsylvania) on a national and even international stage. Shapiro has used money from that fund for sporting event tickets, including the 2023 Super Bowl in Arizona.
Additional reporting by Amanda Fries of Spotlight PA and Manuela Silva of NOTUS.