American baby formula manufacturer ByHeart has issued a comprehensive nationwide recall of all its organic infant formula products, expanding an earlier limited recall as health officials investigate a growing botulism outbreak that has sickened at least 15 infants across 12 states.
Expanding Recall and Hospitalizations
The voluntary recall, announced Tuesday, affects all ByHeart products currently in consumer homes and on store shelves, including ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. This dramatic expansion comes just days after the company initially recalled only two specific lots last Saturday.
According to state and federal health authorities, at least 15 babies have been hospitalized since August after consuming ByHeart formula, with additional cases currently under investigation. Fortunately, no infant deaths have been reported in connection with the outbreak.
Dr. Devon Kuehn, ByHeart's chief medical officer, revealed the company sells approximately 200,000 cans of infant formula monthly through major retailers including Target, Walmart, Albertsons, and Whole Foods, as well as through online channels.
FDA Investigation Reveals Disproportionate Impact
The U.S. Food and Drug Administration is currently examining 84 cases of infant botulism detected since August. Among these cases, 36 infants had consumed formula, with more than one-third having received ByHeart products.
This finding is particularly concerning given that ByHeart represents only about 1% of total U.S. infant formula sales, indicating the brand is significantly overrepresented among affected infants, according to the FDA's statement.
California health officials provided crucial evidence when they confirmed that a sample from an open can of ByHeart formula, which had been fed to a sick infant, contained the specific bacteria type that produces the toxin linked to the current outbreak.
Company Response and Manufacturing Process
ByHeart officials emphasized they implemented this extensive recall "in close collaboration" with the FDA, despite the fact that no unopened products have tested positive for contamination to date.
"This action underscores ByHeart's core mission: protecting babies above all else," the company stated, explaining their precautionary approach.
Dr. Kuehn detailed the manufacturing process, noting that ByHeart produces formula powder at its facility in Allerton, Iowa, then ships it to Portland, Oregon, for canning and distribution. FDA inspectors were present at the Portland plant on Monday as part of the ongoing investigation.
In addition to the comprehensive recall, the company has implemented several safety measures, including testing every formula batch with an independent third-party laboratory, providing health officials with complete access to its facilities, and sharing all test results with regulators as they become available.
Understanding Infant Botulism
Infant botulism is a rare but serious illness that primarily affects babies under one year old, whose developing gut microbiomes make them particularly vulnerable. The condition occurs when infants consume bacteria containing spores that produce toxins within the intestinal tract.
Symptoms parents should watch for include constipation, poor feeding, drooping eyelids, weak muscle tone, difficulty swallowing, and breathing problems. Medical professionals emphasize that infants displaying these symptoms require immediate medical attention.
The sole treatment for infant botulism infection is BabyBIG, an intravenous medication derived from the blood plasma of people who have been immunized against botulism.
Parents and caregivers who have ByHeart formula in their homes should immediately stop using the product and dispose of it properly to prevent potential exposure to the dangerous bacteria.
