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66.7%
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- At least 13 infants across 10 states have been hospitalized with botulism after consuming ByHeart Whole Nutrition Infant Formula between August and November 2024. - Preliminary tests by California health officials detected bacteria that produces botulism toxin in the recalled formula, marking an extremely rare occurrence in powdered infant formula. - ByHeart voluntarily recalled two specific lots of their formula with lot numbers 206VABP/251131P2 and 206VABP/251261P2, both with December 1, 2026 expiration dates. - All affected infants received BabyBIG treatment, the only available therapy for infant botulism, and no deaths have been reported in this outbreak.
• ByHeart secured $90 million in Series B funding to launch its infant formula and advance its pipeline of mom and baby products. • The company's clinical trial with 311 babies met all endpoints, a key step for FDA submission and market entry. • ByHeart's trial included a breastfed reference arm, providing additional data to enhance infant nutrition science. • The funding will support ByHeart's mission to modernize infant nourishment with high-quality, transparent ingredients.
