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.
Credit: FDA States reporting infant botulism linked to ByHeart formula.
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.
“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time,” CDPH Director and State Public Health Officer Erica Pan said in a statement. “We are urging parents to stop using ByHeart formula immediately.”
ByHeart response
ByHeart voluntarily recalled two lots of its Whole Nutrition Infant Formula on November 8. But Tuesday, with the two new cases in two more states and more discussion with the Food and Drug Administration, the company issued a sweeping recall.
“[W]e have decided to voluntarily recall all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks,” ByHeart’s co-founders Mia Funt and Ron Belldegrun said in an announcement on the company’s website.