Botulism Outbreak Expands to All ByHeart Products, 51 Infants Affected

A significant outbreak of infant botulism has affected more than 50 infants across the United States, prompting federal health officials to expand the scope of the investigation to include all products manufactured by ByHeart since production began in March 2022. The U.S. Food and Drug Administration (FDA) announced that contamination may have impacted all ByHeart formula products, which has raised serious concerns among parents and health officials alike.

As of now, the outbreak has been linked to at least 51 cases in 19 states, with the most recent illness reported on December 1, 2023. The Centers for Disease Control and Prevention (CDC) updated its case definition, stating it now includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release.” Previously, the outbreak was believed to involve only 39 cases in 18 states, with health officials first noting a rise in infant botulism cases in August 2023.

ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, initiated a recall of all its products sold in the U.S. on November 11, 2023. This company holds approximately 1% of the U.S. infant formula market and was distributing around 200,000 cans of formula each month before the recall.

The news that ByHeart products might have been contaminated since their inception has caused distress among parents. One such parent, Andi Galindo from Redondo Beach, California, reported that her five-week-old daughter, Rowan, was hospitalized with infant botulism after consuming the formula. Galindo, who sought the formula to supplement her low breast milk supply, expressed her concerns: “That’s a hard one. If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”

In response to the outbreak, the FDA dispatched inspectors to ByHeart’s production facilities in Allerton, Iowa, and Portland, Oregon. However, the agency has yet to release findings from these inspections. Earlier, ByHeart reported that tests by an independent laboratory revealed contamination in 36 samples from three different lots of formula.

Inspection documents have shown that ByHeart has a history of contamination issues. In 2022, the company recalled five batches of formula after one sample tested positive for cronobacter sakazakii. Additionally, the FDA issued a warning letter in 2023, outlining various corrective actions the company needed to undertake. Notably, a ByHeart plant in Reading, Pennsylvania, was shut down in 2023 after inspectors identified problems including mold, water leaks, and insects.

Infant botulism itself is a rare but serious illness, affecting fewer than 200 infants in the U.S. annually. It occurs when infants ingest botulism spores, which then germinate in their intestines, leading to toxin production that impacts the nervous system. Infants are particularly vulnerable until about age one due to immature gut microbiomes.

Symptoms of infant botulism can take up to 30 days to appear and may include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression. In severe cases, affected infants may exhibit “floppy” behavior and have difficulty swallowing or breathing. The only effective treatment for infant botulism is known as BabyBIG, an intravenous medication derived from the pooled blood plasma of adults immunized against botulism.

Experts emphasize that the risk remains for affected infants, advising families to avoid using the recalled formula. In light of the outbreak, several families whose children have been treated for botulism after consuming ByHeart formula have initiated lawsuits against the company. These lawsuits allege that ByHeart’s formula was defective and that the company acted negligently, seeking compensation for medical expenses and emotional distress.

The situation continues to develop as health officials monitor the outbreak closely and families affected grapple with the implications of this contamination.