31 babies sickened as recalled ByHeart formula lingers on Pa. shelves

At least 31 infants hospitalized across 15 states—including one Pennsylvania case—have contracted infant botulism after consuming ByHeart Whole Nutrition infant formula, according to FDA data as of November 19, 2025. The outbreak, which began in mid-August 2025, prompted ByHeart to issue a voluntary recall of all lots of its powdered formula in both standard cans and single-serve Anywhere Pack sticks. No deaths have been reported, but the persistence of recalled products on store shelves months after the recall announcement has alarmed federal health officials and parents alike. The contamination stems from Clostridium botulinum, a bacterium that produces a toxin in infants' intestines, causing symptoms that develop gradually over weeks. Affected babies experience poor feeding, loss of head control, drooping eyelids, and a "floppy" sensation, with some developing difficulty swallowing or breathing. All 31 hospitalized infants received BabyBIG immunoglobulin intravenous treatment. The illnesses span a timeline from August 9 through November 13, 2025. Pennsylvania parents who purchased ByHeart formula—sold at major retailers including Amazon, Kroger, Target, Walmart, and Whole Foods—face particular concern given the state's connection to the outbreak and the manufacturing facility itself. An FDA inspection of ByHeart's Pennsylvania infant formula manufacturing facility in January 2024 cited unsanitary conditions, potential contamination of raw materials, and lack of pest control. The company had also received a warning letter in 2023 after a 2022 recall involving Cronobacter sakazakii contamination. Despite the expanded recall, the FDA reported that ByHeart formula remained visible on store shelves across multiple states as recently as November 2025. State health officials have collected unopened samples for laboratory testing, though detection of the botulism bacterium in formula is notoriously difficult. The FDA cautioned that negative test results do not rule out the presence of Clostridium botulinum. "Consumers are warned not to use the product even if it does not look or smell spoiled," the agency stated. Parents with ByHeart formula should immediately stop using it and consult their pediatrician about safe feeding alternatives. Any infant showing signs of botulism—including constipation, weakness, poor feeding, or reduced muscle tone—requires immediate emergency care.