A nationwide recall has been issued for two lots of ByHeart Whole Nutrition Infant Formula after federal health officials linked the product to 13 cases of infant botulism across 10 states, including one in Oregon. The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention announced the voluntary recall on Nov. 8, following reports of hospitalizations among infants who consumed the formula.
The cases came to light when the California Department of Public Health observed an uptick in infant botulism incidents among babies fed ByHeart's powdered formula, prompting them to notify the CDC. According to the agencies, preliminary testing on an open can of the formula fed to an affected infant revealed the presence of bacteria that produce botulinum toxin. The FDA stated that further testing of leftover formula is ongoing, with results anticipated in the coming weeks.
ByHeart, the company behind the formula, has agreed to the voluntary recall but has pushed back against the findings. In a statement, the company denied the validity of the test that detected the toxin and announced it was undertaking its own additional testing. "We are conducting our own additional testing," ByHeart said, emphasizing their commitment to safety while questioning the initial results.
The recalled lots include Lot 206VABP/251261P2 with a use-by date of Dec. 1, 2026, and Lot 206VABP/251131P2, also with a use-by date of Dec. 1, 2026. These batches were manufactured on April 23 and May 6, respectively, and were primarily distributed in July and August, according to the company. The FDA noted that the formula was sold online and nationwide, but the recalled products represent less than 1% of all infant formula sold in the United States, alleviating concerns about potential shortages.
All 13 reported cases have led to hospitalizations, the CDC reported as of Nov. 10, with no deaths recorded. The incidents span 10 states, though specific states beyond Oregon and the involvement of California in the initial detection were not detailed in the announcements. One case was confirmed in Oregon, highlighting the national scope of the issue.
Infant botulism is a rare but serious illness caused by the bacterium Clostridium botulinum, which can produce toxins in a baby's intestines. According to the CDC, symptoms typically begin with constipation, poor feeding, loss of head control, and difficulty swallowing. If untreated, it can progress to flaccid paralysis, potentially causing breathing difficulties and requiring extended hospital stays.
The Cleveland Clinic provides further details on the condition, listing symptoms such as choking during feeding, a weaker suck or poor feeding, lack of facial expressions, inability to lift the head, and other signs of muscle weakness or paralysis. Additional indicators include weakness or decreased muscle tone, particularly starting from the top of the body and limbs, making the baby feel 'floppy' and hindering their ability to reach or grab objects. Bowel movement changes, like extended periods without pooping, are also common.
ByHeart has advised consumers who possess the recalled cans to dispose of them immediately and has offered replacements at no cost. The company's response underscores a proactive stance amid the controversy, as they work to address customer concerns while conducting independent verifications.
This recall comes against the backdrop of heightened scrutiny on infant formula safety in the U.S., following the major shortage in 2022 triggered by contamination issues at a major manufacturer's plant. That crisis, involving Abbott Nutrition, led to widespread recalls and supply disruptions, prompting federal interventions to import formula from abroad. While the current ByHeart recall is much smaller in scale, it reignites discussions about manufacturing standards and regulatory oversight in the industry.
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing. If left untreated, infants may experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
That's according to the CDC's description of the illness, which emphasizes the importance of early detection and treatment. Health experts recommend that parents monitor their infants closely for these symptoms and seek immediate medical attention if they appear, especially in light of recent cases.
The involvement of multiple states in the botulism cases points to the widespread distribution of the affected lots. The FDA's assurance that this recall won't exacerbate supply issues is a relief for parents still wary from the 2022 shortages, but it also highlights ongoing vulnerabilities in the infant nutrition market. ByHeart, a relatively new player founded in 2020, positions itself as a premium, science-backed option, but this incident could impact consumer trust.
Officials from the California Department of Public Health played a pivotal role by first noticing the cluster of cases and alerting federal agencies. Their vigilance underscores the collaborative network between state and federal health bodies in monitoring public health threats. As testing continues, both the FDA and CDC have urged parents to check their formula cans against the recalled lot numbers and to report any adverse events.
Looking ahead, the results of the ongoing FDA tests and ByHeart's independent evaluations could clarify the source of the contamination and potentially lead to broader industry reforms. In the meantime, pediatricians are advising families to consult healthcare providers for alternative feeding options if they've used the recalled product. No further cases have been reported since Nov. 10, but surveillance remains active.
The broader implications of this recall extend to food safety regulations, with advocates calling for stricter testing protocols for powdered formulas, which are particularly susceptible to bacterial contamination if not handled properly. As the story develops, health authorities continue to prioritize infant safety, ensuring that such incidents are contained swiftly to prevent wider outbreaks.