What is the ByHeart formula recall about?

The ByHeart organic baby formula company has recalled all of its products sold in the U.S. after 15 infants were hospitalized with suspected botulism linked to consuming their formula.

How many infants have been affected by the ByHeart formula botulism outbreak?

As of November 10th, a total of 84 infants have been affected by the larger botulism outbreak, with 15 of those cases linked to ByHeart formula.

What is the FDA doing in response to the ByHeart formula recall?

The FDA is conducting an ongoing investigation into the ByHeart formula recall, and the company is providing the agency with unrestricted access to all of its facilities and products.

Home / Health / ByHeart Recalls All Formulas Amid Botulism Outbreak

ByHeart Recalls All Formulas Amid Botulism Outbreak

13 Nov

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Summary

ByHeart recalls all formula sold in the U.S. due to botulism outbreak
15 infants hospitalized after consuming ByHeart formula
FDA investigation ongoing, company providing full access to facilities

ByHeart Recalls All Formulas Amid Botulism Outbreak

On November 13, 2025, the organic baby formula company ByHeart announced a voluntary recall of all its products sold in the United States. This decision came after the Food and Drug Administration (FDA) informed the company on November 10th that two additional cases of botulism had been linked to ByHeart formula, bringing the total number of affected infants to 15.

The initial recall on November 11th had only covered two specific production lots, but ByHeart's cofounders Mia Funt and Ron Belldegrun said they decided to expand the recall to include all ByHeart formulas out of an abundance of caution. No deaths have been reported, but the cases are part of a larger outbreak involving 84 infants across the country.

ByHeart is cooperating fully with the ongoing FDA investigation, providing unrestricted access to their facilities and products. The company has also conducted its own extensive testing on all batches and promised to share the results as they become available. In the meantime, ByHeart has instructed consumers to immediately discard any leftover formula, though the CDC has asked them to store it for potential testing if their infant develops botulism symptoms.

Disclaimer: This story has been auto-aggregated and auto-summarised by a computer program. This story has not been edited or created by the Feedzop team.