Federal health officials have broadened the scope of an outbreak of infant botulism linked to the recalled ByHeart baby formula. This expansion now encompasses all reported illnesses since the company commenced production in March 2022. The U.S. Food and Drug Administration (FDA) announced that investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever produced.
The outbreak currently includes at least 51 infants from 19 states, according to the U.S. Centers for Disease Control and Prevention (CDC). The updated case definition now includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release.” The most recent case was reported on December 1, 2023.
Previously, health officials had identified 39 suspected or confirmed cases of infant botulism across 18 states since August 2023. This surge in cases was initially reported by California’s Infant Botulism Treatment and Prevention Program, which noted an increase in treatment for infants who had consumed ByHeart formula. The newly defined cases include an additional 12 infants, including two from the original timeline and ten from December 2023 to July 2025.
ByHeart, a New York-based manufacturer of organic infant formula established in 2016, recalled all its products sold in the U.S. on November 11, 2023. The company, which commands approximately 1% of the U.S. infant formula market, had been distributing around 200,000 cans of its products each month.
Parents have expressed deep concern regarding the potential contamination of ByHeart products over an extended period. Andi Galindo, a mother from Redondo Beach, California, shared her distress after her 5-week-old daughter, Rowan, was hospitalized in December 2023 due to infant botulism linked to the formula. Galindo, 36, noted that she chose ByHeart to supplement her low breast milk supply based on a lactation consultant’s recommendation, stating it was “very natural, very gentle, very good for the babies.”
Another parent, Amy Mazziotti, 43, of Burbank, recounted how her son, Hank, developed botulism in March after consuming ByHeart formula. She expressed relief that these cases are now part of the broader investigation, saying, “I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick.”
In a statement released on Wednesday, ByHeart officials indicated their cooperation with federal authorities to understand the full scale of the situation. They stated, “The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination.”
Federal inspectors visited ByHeart facilities in Allerton, Iowa, and Portland, Oregon, last month, where the formula is produced and packaged. However, the FDA has not released the results of these inspections. The company had previously disclosed that tests from an independent laboratory revealed that 36 samples from three different lots contained the bacteria responsible for infant botulism. ByHeart acknowledged the risk of contamination across all product lots on its website.
Dr. Jennifer Cope, a CDC scientist leading the investigation, noted that contamination appeared to persist across various production runs and raw material lots. “They couldn’t isolate it to specific lots from a certain time period,” she explained.
This incident is not the first for ByHeart. In 2022, the company recalled five batches of formula after a sample tested positive for a different germ, cronobacter sakazakii. Additionally, the FDA sent a warning letter to ByHeart in 2023, indicating areas requiring corrective action. One of its plants in Reading, Pennsylvania, was shut down after inspectors identified mold, water leaks, and insect issues.
Infant botulism is a rare but serious condition that affects fewer than 200 babies annually in the U.S. It occurs when infants ingest botulism bacteria that produce spores in the intestines, generating a toxin that can harm the nervous system. Babies remain vulnerable to the condition until around age one, as their gut microbiomes are not sufficiently developed to combat the toxin.
Symptoms can take up to 30 days to manifest and may include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression. Babies may appear “floppy” and experience issues with swallowing or breathing. The only treatment available for infant botulism is BabyBIG, an intravenous medication derived from pooled blood plasma of adults immunized against botulism. This treatment is developed by California’s infant botulism program and is the sole source globally.
Several families of infants treated for botulism after consuming ByHeart formula have initiated lawsuits against the company. These lawsuits, filed in federal courts, claim that the formula was defective and that ByHeart acted negligently in its sale. They seek compensation for medical expenses, emotional distress, and other damages.
The ongoing investigation and the serious implications of this outbreak highlight the necessity for stringent safety measures and accountability within the infant formula industry, ensuring the health and safety of vulnerable populations such as infants.
