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.