FDA Reports Show Repeated Safety Issues During Audits of Baby Formula Company at Center of Botulism Outbreak

A baby formula company at the center of an ongoing nationwide infant botulism outbreak had persistent sanitary problems during repeated site inspections in recent years, according to records released by the FDA. 

In a bulletin published on November 26th, the FDA stated that a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition Formula have been reported from 17 states. The FDA is still working to determine the source of contamination and has advised parents and caregivers not to use any ByHeart infant formula, regardless of batch test results.  

In late November, ByHeart stated that they “cannot rule out the risk that all ByHeart formulas across all product lots may have been contaminated.”

The company stated that once they learned of the outbreak, they tested 36 samples from three lots and received positive test results for Clostridium botulinum Type A in five of the samples. 

“We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples,” the company stated.

The Facility allowed “significant pest activity”

The FDA bulletin links to a February 2025 inspection report, which found that ingredients were not held under conditions to prevent adulteration, the facility did not take actions to eliminate harborage areas for rodents, did not have clear barriers separating hygiene zones, and did not monitor baghouse differential pressures.

The report states that inspectors discussed with facility management “the firm allowing for significant pest activity in areas,” as well as insufficient written procedures for environmental monitoring, failure to secure doors, failure to collect swabs during production for pathogen testing, and failure to fix stains on the floors and ceiling and water leaks, among others. 

A 2023 inspection report of the facility found dozens of cracks in equipment, floors, and the roof, which can harbor foodborne pathogens. Inspectors also noted that the facility lacked a written sanitation preventive control, monitoring, corrective action, and verification procedures.  

The report also stated that the company had received almost 2,000 customer complaints regarding products produced by its base powder. 

In an establishment inspection report from January 2024, the authors wrote that two years prior, during a June 2022 inspection by the FDA, auditors made four key observations about the facility. These include a failure to maintain the facility in a clean and sanitary condition, the lack of sufficient written sanitation preventive control, monitoring, corrective action, and verification procedures, the failure to properly calibrate measuring devices, and the fact that a person tasked with monitoring infant formula quality control procedures was directly responsible for the matters they were auditing.
A partially-redacted warning letter issued by the FDA in August 2023 documented bacteria, a leaking roof, and unsanitary conditions, and violations of infant formula requirements for current good manufacturing practice, quality control procedures, quality factors, records and reports, and notifications.

The 2024 inspection report states that the company had a positive test for Cronobacter in production and storage areas. In response, the company only held and destroyed one lot of infant formula and “did not work with its third-party contract manufacturer to further investigate the origin or root cause of the finished product testing positive for the pathogen.” 

Families sue formula company

NBC News reported last month that at least four families have sued ByHeart, saying their babies contracted botulism from contaminated formula. The families describe spending days and weeks in the hospital with their babies hooked up to IVs and feeding tubes. 

“If there’s a product that should be safe, it should be infant formula, “ Bill Marler, a lawyer representing three of the families, said. 

Infants under 12 months old are at the highest risk from infant botulism, which is considered a medical emergency. Symptoms of infant botulism include constipation, poor feeding, loss of head control, and difficulty swallowing. The systems can take several weeks to develop.

The inspection reports published by the FDA highlight the importance of carrying out frequent internal audits to ensure that environmental monitoring procedures and sanitation, hygiene, and pest control guidelines are being met. The illnesses that have resulted from the outbreak, and the subsequent recall, have also shown the potentially devastating consequences that can arise from failure to resolve shortcomings found in previous auditor visits. To learn more about the importance of internal audits and how to get started, download the recent Rootwurks free guide Prevent Recalls: A Guide to Internal Audits.”