At least 31 infants across the United States have developed botulism linked to powdered formula from ByHeart, with health officials confirming the presence of Clostridium botulinum—the bacteria responsible for the toxin—prompting a nationwide recall of specific product batches, reports BritPanorama.
The California Department of Health tested an opened can of ByHeart formula that had been fed to an infant, detecting the harmful bacterial spores. This led to an expanded recall, which now includes all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products. Days later, an independent testing lab hired by the manufacturer also found the bacteria in unopened cans of the formula.
Concerns are mounting as officials reassess earlier cases of infant botulism, with the potential for the outbreak’s number of illnesses to rise. Attorney Bill Marler, a food poisoning litigation specialist, described this outbreak as “certainly the largest foodborne illness outbreak that I’ve heard of in 32 years due to infant formula” and expressed grave concerns about the situation.
Dr. Steve Abrams, a neonatologist and pediatric nutrition expert, noted the unprecedented level of sickness among infants due to formula contamination. He remarked, “This is an insane level of patients, babies affected,” emphasizing the rarity of such widespread cases linked to formula. Meanwhile, he voiced concerns that public awareness regarding the recall and the outbreak’s seriousness remains insufficient, with reports indicating cans of ByHeart formula still on store shelves even after the recall announcement.
Searching for the source
Questions remain regarding how the formula became contaminated. ByHeart has stated it is cooperating with the FDA to thoroughly investigate every aspect of its production, from ingredient sourcing to manufacturing processes. Botulinum spores can survive pasteurization, creating unique challenges for food safety.
Dr. Kristin Schill, a food microbiologist, explained that the spores, akin to seed forms, can be resilient in adverse conditions. This adds to the complexity of tracking contamination sources, particularly with ByHeart’s use of whole milk powder and whey in its formulas. While low concentrations of botulinum spores have been found in milk powder before, the current situation requires a critical evaluation of contaminated formula levels.
The only treatment for infant botulism
Stephen Dexter, father of an infant affected by the outbreak, turned to ByHeart formula after struggling with low breast milk production from his wife. However, after noticing concerning changes in their daughter Rose’s health, they found themselves in the emergency room. Medical professionals suspected either muscular dystrophy or botulism.
Dr. Erica Pan, California’s state public health officer, highlighted the subtle symptom progression associated with infant botulism, making early detection challenging. Treatment options include BabyBIG, an orphan drug created from human plasma, which has been effective in treating the condition. It costs nearly $70,000 per treatment but significantly reduces hospital stay lengths.
From August 1 to November 19, 107 infants received BabyBIG treatment in the ongoing botulism cases. Medical teams began administering it to Rose before her diagnosis was confirmed, and subsequent stool tests validated the medical team’s suspicions.
‘I feel like it was a nightmare’
The ongoing investigations into the infant botulism cases reveal challenges in pinpointing the source of infection. The California health agency noted concerning patterns in recent months, particularly among infants using ByHeart formulas, which significantly exceed expected proportions.
Amid the turmoil, the Dexters learned about the formula’s potential risks too late. Following a recall notification, they ceased administering the product to Rose, but the emotional impact of the situation lingers. “I feel like it was a nightmare, all the things that happened for us,” admitted Yurany Dexter, reflecting on her struggles with breastfeeding and the subsequent health crises their daughter faced.
Both parents expressed frustration and incredulity at the circumstances, highlighting the emotional weight carried by families affected by the recalls. As care providers and regulators race to uncover the outbreak’s causes, experts advocate for heightened awareness to mitigate risks in vulnerable populations.
Ongoing investigations aim to prevent further cases of infant botulism, as the urgency to identify the contamination source intensifies.
