The maker of a specialty baby formula that touted having the “cleanest ingredients” and a “Purity Award” is recalling all of its products and lots amid an ongoing, multi-state outbreak of infant botulism.
The outbreak was initially announced over the weekend by California and federal health officials. At that time, 13 cases of infant botulism had been flagged across 10 states. But on Tuesday, the outbreak expanded to 15 cases in 12 states. All 15 infants have been hospitalized, but no deaths have been reported.
States reporting infant botulism linked to ByHeart formula.
Credit:
FDA
The California Department of Public Health (CDPH) was the first to flag the outbreak. The department is the world’s sole source of the infant botulism treatment called BabyBIG, which is made of human-derived anti-botulism antibodies and is effective at easing symptoms and shortening recovery times. California health officials noted an unusual uptick in case reports and found they were linked to a specific formula: ByHeart Whole Nutrition Infant Formula. The department then did its own testing of some leftover formula, which was positive for the bacterium that causes botulism, Clostridium botulinum.
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