ByHeart Formula Botulism Outbreak: CDC Update & Warning (Dec 2025)

Atlanta, GA – December 10, 2025 – The Centers for Disease Control and Prevention (CDC) today provided an update on the investigation into a multi-state outbreak of infant botulism linked to ByHeart infant formula. What began as a concerning cluster of cases has now expanded to encompass 51 sick infants across 19 states, all requiring hospitalization and treatment with BabyBIG®, an anti-toxin. Whereas no deaths have been reported, the outbreak underscores the critical role of rapid public health response in safeguarding infant health and highlights the complexities of identifying and containing foodborne illnesses.

Infant botulism is a rare but serious illness caused when a baby ingests spores of the bacterium Clostridium botulinum. These spores can germinate in the infant’s gut, producing a toxin that causes paralysis. Symptoms often commence with constipation, followed by difficulty feeding – a noticeable weakness in sucking and swallowing – a diminished or altered cry, and a loss of head control. Early recognition of these signs is crucial, as prompt treatment with BabyBIG® can significantly reduce the severity of the illness.

Expanding Timeline and Continued Warning

The CDC’s investigation, conducted in collaboration with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP), has revealed that cases date back to December 2023 – a wider timeframe than initially suspected. This expanded date range was determined after assessing previously reported cases and recognizing a common link to ByHeart formula. The CDC continues to strongly advise parents to immediately discontinue use of any ByHeart Whole Nutrition infant formula, even if it appears to be available for purchase in stores or online. Laboratory testing has confirmed the presence of botulism spores within the formula, directly linking it to the illnesses.

The speed with which the CDC responded to this outbreak is notable. Typically, the U.S. Sees around 150-180 individual cases of infant botulism each year. An outbreak of this scale is, as Dr. Jennifer Cope, chief of the Enteric Diseases Epidemiology Branch, stated, “unprecedented.” On November 7, 2025, the CDC was alerted by the IBTPP to a concerning rise in cases among infants consuming ByHeart formula. Within hours, CDC and the U.S. Food and Drug Administration (FDA) were in direct communication with ByHeart, urging them to capture immediate action to remove potentially contaminated formula from the market. By November 8th, a public warning was issued, advising parents to stop using two specific lots of the formula. This was quickly expanded on November 11th to a blanket recommendation to cease use of all ByHeart infant formula.

Laboratory Investigation and Real-Time Data Evaluation

The CDC’s response wasn’t limited to public warnings. CDC laboratories are actively analyzing clinical samples collected from sick infants, as well as samples from open containers of ByHeart formula recovered from the homes of affected families. This ongoing laboratory work is critical to understanding the source and extent of the contamination. The outbreak team is continuously evaluating data as it becomes available, allowing for a dynamic and responsive approach to the investigation. More detailed information about the outbreak is available on the CDC website.

What Does This Mean for Parents?

The primary message for parents remains clear: do not use ByHeart infant formula. If your infant has consumed ByHeart formula and is exhibiting symptoms of botulism – constipation, difficulty feeding, a weak cry, or lack of head control – seek immediate medical attention. It’s important to remember that infant botulism, while serious, is treatable with prompt administration of BabyBIG®.

This outbreak serves as a stark reminder of the potential risks associated with infant formula and the importance of rigorous quality control measures. While infant formula is a life-saving product for many families, it’s essential that manufacturers adhere to the highest standards of safety and sanitation. The FDA is currently investigating ByHeart’s manufacturing processes to determine the source of the contamination and prevent future outbreaks. The FDA’s investigation is ongoing, as reported by news sources.

The Role of Rapid Response and Surveillance

This incident highlights the effectiveness of the CDC’s rapid response capabilities. The agency’s ability to quickly mobilize resources, collaborate with state and local health departments, and conduct laboratory investigations was instrumental in identifying the outbreak and issuing timely warnings. The CDC’s surveillance systems, which continuously monitor for unusual patterns of illness, played a crucial role in detecting the initial cluster of cases. Further updates on the investigation are being provided by the Centers for Disease Control and Prevention.

Looking Ahead: Continued Monitoring and Prevention

The CDC’s work doesn’t finish with the immediate response. The agency will continue to monitor for new cases of infant botulism and investigate any potential links to ByHeart formula. The FDA’s investigation into ByHeart’s manufacturing processes will be critical to identifying the root cause of the contamination and implementing measures to prevent future outbreaks. This includes a thorough review of the company’s quality control procedures, sanitation practices, and ingredient sourcing. The CDC will also continue to work with healthcare providers to raise awareness of infant botulism and ensure that they are equipped to recognize and treat the illness promptly. Recent updates from Marler Blog detail the FDA’s ongoing efforts to update the body count related to this outbreak.