Tag Archives: Infant Botulism

Beltway Beat

FDA Calls on Infant Formula Industry to Better Safeguard Against Contaminants Introduced through their Supply Chain

By Food Safety Tech Staff
No Comments

On July 13, 2026, the U.S. Food and Drug Administration announced on their website that the Agency sent a letter to the infant formula industry and their supply chain partners highlighting multiple recent public health events where risks were introduced through the supply chain and to call for increased vigilance by industry to ensure the safety of ingredients and finished infant formula products.

FDA has investigated two multistate outbreaks of infant botulism associated with two separate brands of powdered infant formula — ByHeart, Inc., and Nara Organics, Inc. — resulting in voluntary recalls and an ongoing FDA investigation into the shared ingredient suppliers. Likewise, a global contamination event occurring in late 2025 through early 2026 resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries, traced to contaminated arachidonic acid (ARA) oil used as an ingredient in infant formula. This prompted multiple global downstream recalls, and a supplier of ARA oil being added to multiple import alerts.

Manufacturer Responsibility: Know Your Suppliers

The FDA expects manufacturers to exercise substantive oversight of their suppliers, including understanding where their ingredients come from, how they are produced, what risks they may carry, and whether those risks are effectively controlled. When a contaminated ingredient or supplier concern is identified, whether by FDA or through industry’s own monitoring, manufacturers are expected to act swiftly to assess and address the risk.

The FDA also recommends that infant formula manufacturers and their supply chain partners stay abreast of applicable recall notifications, outbreak investigations and import alerts, which may serve as important safety signals. Experience has shown that ignoring or downplaying these safety signals can lead to increased risks to infants and preventable public health events.

FDA Actions

The FDA acknowledges the challenges in managing the risks related to spore-forming microbes in infant formula ingredents and recognizes there might not be a single approach for addressing them.  The Agency is prepared to work with industry to identify best practices and will continue to solicit advice from experts in academia and international scientific bodies, such as the Codex Committee on Food Hygiene and the International Commission on Microbiological Specifications for Foods.

The FDA also is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks associated with powdered infant formula and has completed initial surveillance to better understand the prevalence of Clostridium botulinum in powdered milk, the results of which are available on FDA’s Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.

Beltway Beat

FDA and CDC Leading Multistate Outbreak Investigation of Infant Botulism from Infant Formula

No Comments

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states. Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.

The company posted a letter on the company’s website. https://byheart.com/ that stated It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. 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. Your baby’s safety is, and always will be, our biggest priority. Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. 

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had consumed ByHeart Whole Nutrition infant formula.

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. Investigations remain ongoing, but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism.  Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

FDA contacted the firm and requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.

FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula.

Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

According to the Times article, FDA inspection reports detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, the findings raise concerns about the company’s safety record.

For example, in July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant. When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.

Months later, FDA inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The FDA classified the inspection at its highest tier of concern.