Botulism Outbreak Spreads: ByHeart Formula Recall Expanded as Hospitalization Cases Rise to 31

ByHeart markets its formula as being the "closest to breast milk" with organic ingredients.

ByHeart has confirmed that third-party testing discovered bacteria capable of causing botulism in some of their infant formula products, coinciding with US health officials reporting an increase in hospitalized infants with the illness.

Testing was conducted by an independent laboratory based in Washington state, according to ByHeart's website statement. As of Wednesday, health officials reported that the number of infants hospitalized with suspected or confirmed botulism linked to the recalled formula has increased to 31 cases.

The company stated they immediately informed the Food and Drug Administration about these test results. "We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again," the company announced.

ByHeart initiated a recall of two formula lots on November 8, which was expanded nationwide on November 11. Despite these measures, FDA officials have reported that state inspectors continue to find recalled ByHeart products on store shelves as the outbreak spreads.

"All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online," emphasized the FDA. "This includes all formula cans and single-serve 'anywhere pack' sticks."

The agency has also issued warnings to international consumers who may have purchased ByHeart formula online to discontinue use. The FDA's previous update on November 14 reported 23 affected infants. The outbreak, which began as early as August 9, has now spread to 15 states, up from the previously reported 13.

"We shouldn't tolerate this," FDA Commissioner Marty Makary stated in an interview with Bloomberg, emphasizing the agency's commitment to addressing the outbreak rapidly. "I'm not messing around when I say this, I don't want to see a single kid get sick" due to delays in the recall process.

Despite gaining popularity during the nationwide formula shortage in 2022, ByHeart represents only approximately 1% of all US infant formula sales, according to FDA data.