An FDA Response to Recent Cases of Infant Botulism
An FDA spokesperson noted that it’s premature to make definitive conclusions regarding specific ingredients, manufacturing processes, or other factors highlighted in Nara’s study. Both ByHeart and Nara Organics have stated their commitment to cooperating with health authorities as they investigate these issues.
According to the FDA, ByHeart and Nara Organics represent a modest share of the U.S. infant formula market, approximately 1%. Despite this, experts in infant nutrition assert that the overall supply in the country remains remarkably secure.
Dr. Sharon Nachman, director of pediatric infectious diseases at Stony Brook Children’s Hospital, emphasized that the recent cases should not instill fear in families regarding the broader safety of infant formula. “We don’t want families to think this is something they would expect to see in all formula,” she explained. However, two outbreaks involving the same pathogen occurring within such close proximity raises legitimate concerns.
Prolonged Recovery for Affected Infants
The Centers for Disease Control and Prevention (CDC) has released an unpublished report that underscores the serious nature of infant botulism, stating that recovery can be a prolonged process even after hospital discharge. Rehabilitating the signaling pathways between nerves and muscles can take several months, making recovery slow and challenging.
Myra Brooks, a disease intelligence officer at the CDC, analyzed the medical records of 46 of the 48 infants impacted by the ByHeart outbreak. None of these children exhibited fevers that could suggest alternative illnesses, which points to the unique symptoms associated with botulism.
Among the 46 infants, significant findings include:
- 91% exhibited problems with the sucking reflex
- 87% experienced constipation
- 76% were unable to lift their heads
- 24% faced breathing difficulties
More than half of these infants (61%) required extra oxygen for respiratory support or had to be fed through nasal tubes. Furthermore, 11% needed intubation or the surgical insertion of feeding tubes.
Brooks noted that approximately two-thirds of the infants required specialized treatment to rehabilitate their feeding capabilities. Her findings are poised for publication in an upcoming issue of the CDC’s Morbidity and Mortality Weekly Reports.
Personal Accounts of Impact
Hank Mazziotti, now nearly two years old, was hospitalized over a year ago due to infant botulism. His mother, Amy, revealed that he still struggles with bowel movements without the aid of laxatives, a painful routine that occurs weekly.
“It’s very painful to vomit and poop at the same time,” Amy recounted. “It’s a weekly thing,” reflecting the challenges they continue to face.
After purchasing ByHeart formula in mid-February 2025 to supplement her breast milk supply, Amy reported that Hank’s constipation issues began shortly thereafter. By early March, her once-active six-month-old was lethargic, hardly drinking from the bottle, and showing noticeable signs of distress.
Investigative Efforts into Botulism Sources
Tests conducted by the FDA revealed the presence of Clostridium botulinum in both ByHeart’s formula and in powdered milk ingredients provided by their supplier, Dairy Farmers of America, based in Kansas City, Kansas. Authorities have not yet determined the pathway for bacterial contamination in ByHeart’s products but are diligently investigating processes, ingredients, and production conditions.
In the wake of the ByHeart recall, the company offered customers discount codes for Nara Organics as an alternative. A spokesperson clarified that ByHeart and Nara are independent entities with no shared corporate, financial, contractual, operational, or manufacturing ties.
A Nara Organics representative referenced an Instagram post from company founder Esther Hallam, who stated that no Nara products had tested positive for Clostridium botulinum, which led to a voluntary recall being issued “out of an abundance of caution.”
While Nara prides itself on using a testing method known as SRC to detect bacteria, it’s important to note that this method does not specifically target Clostridium botulinum and is not mandated by the FDA.
Dr. Stephen Abrams, a neonatologist and professor at the University of Texas at Austin, cautioned against the misconception that products marketed as organic, premium-priced, or heavily promoted on social media are inherently safer. “There’s no evidence of that,” he stated, emphasizing that all infant formulas must adhere to the same rigorous safety protocols.
Regulatory Actions and Future Directions
The recall follows the Department of Health and Human Services’ announcement of Operation Stork Speed, directed by Robert F. Kennedy Jr. This initiative aims to enhance the safety of infant formula ingredients and emphasizes heightened testing for heavy metals and contaminants.
“Infant botulism associated with infant formula remains extremely rare, but any number of cases is too many,” stated HHS spokesperson Emily Hilliard. “That’s why the FDA is intensifying testing and oversight and accelerating scientific investigation through Operation Stork Speed to better understand risks and bolster safety measures across the infant formula supply chain.”
Northeastern University’s Detwiler recommended a shift toward proactive prevention and enhanced monitoring of infant formulas before outbreaks occur. “If the same rare disease occurs twice within a few months, associated with a product intended for infants, the focus must shift to whether we can learn enough from these warning signs to prevent future cases,” she asserted.
