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Some say FDA should have acted quicker to help implement ByHeart infant formula recall

Some say FDA should have acted quicker to help implement ByHeart infant formula recall

The ongoing outbreak of infant botulism traced to ByHeart formula, and the recalls surrounding the situation, is sending shock waves though the country, with food safety leaders calling out the government’s response to the chain of events.

The outbreak has sickened at least 51 babies, dating back to December 2023. The vast majority of the babies became ill starting in August this year. All of the sick infants have been hospitalized with severe symptoms, but none have died.

ByHeart initially recalled two lots of its powdered infant formula on Nov. 8. The company expanded the recall to include all of its formula on Nov. 11.

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