ByHeart Expands Recall of Infant Formula Nationwide as 15 Patients Get Impacted by Botulism Outbreak
ByHeart infant formula made headlines after two of its lots were recalled over an infant botulism outbreak. Now, the recall is expanded after more cases were reported. This time, all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack are being recalled from across the nation. The company confirmed the expansion after tests by the California Department of Public Health found contaminated formula in patient homes. Genetic tests confirmed the match between the bacteria that infected the patient and those found in the infant formula. According to the FDA, the expanded recall also includes unexpired lots of formula cans and single-serve “anywhere” sticks. The botulism outbreak has impacted 15 infants as of now.
Another major reason that prompted the recall expansion was the increasing number of cases of suspected botulism. As of today, 15 infants from 12 States have become victims of the multi-state outbreak, testing either positive for the disease or suspected to be positive. Previous tests couldn't detect the presence of Clostridium botulinum — the disease-causing bacteria — in ByHeart's infant formula products. However, the recent epidemiologic and laboratory data show its presence in the baby formula, causing botulism in infants across different regions. Although all 15 infants were hospitalized, no deaths have been reported.
Information like age and gender for 14 infants is available. The FDA revealed the age range of 14 of these infected infants is from 16 to 157 days old, and 7 (50%) of them are females. In the latest update, the local and State health officials are interviewing caregivers about the food fed to the infants in the months before they got infected. The IBTPP (Infant Botulism Treatment and Prevention Program) informed the agency that 84 infants have received botulism treatment between August 1, 2025, through November 10, 2025. Among the 84 infants, 36 reportedly consumed any powdered formula. Since 15 patients out of the 36 infants are infected with botulism, more than 40% consumers have shown symptoms of contamination. This highlights the severity of the contamination and the outbreak.
Additional testing is underway, and the results will come out in the upcoming weeks. The agency has highlighted the need for constant testing because negative tests for botulism don't rule out the presence of the bacteria in the product. However, the ByHeart formula products account for only 1% of baby food products sold across the U.S. Hence, this recall won't be problematic for parents and caregivers to feed formula food to their babies. Botulism is a life-threatening disease caused because of the toxins produced by bacteria called Clostridium botulinum, as per Mayo Clinic. Constipation, poor feeding, loss of head control, and difficulty swallowing are some of the symptoms of the disease.
It's best to watch out for the symptoms for a week, as it takes time to develop. The FDA recommended parents and caregivers check their stocked baby food products to make sure they don't have the affected products. If a child is showing any of the above-mentioned symptoms, immediate doctor's consultation will be required. The agency suggested taking a picture or video of the information at the bottom of the package if they have the product in their pantry. If a child develops symptoms of botulism, the health department would collect the contaminated baby formula for testing.
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