Investigation Links Infant Botulism Outbreak to ByHeart Formula

The U.S. Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state health officials, is investigating a multistate outbreak of infant botulism that has been linked to ByHeart Whole Nutrition Infant Formula. The ongoing investigation has determined that all ByHeart Whole Nutrition Infant Formula products, including all lots of cans and single-serve “anywhere pack” sticks, have been recalled. Parents and caregivers are strongly advised to stop using any ByHeart infant formula products immediately.

The outbreak, first identified in November 2025, has led to numerous infant illnesses across multiple states. As of January 23, 2026, a total of 51 illnesses have been reported, all of which resulted in hospitalization. No deaths have been reported in connection with this outbreak. The last reported illness onset was on December 1, 2025. States reporting cases include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.

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Symptoms of infant botulism can include constipation, poor feeding, loss of head control, and difficulty swallowing, which can potentially progress to breathing difficulties and respiratory arrest. These symptoms may take several weeks to develop after the infant has ingested contaminated formula. The FDA and CDC recommend that if a child consumed ByHeart formula and is exhibiting any of these symptoms, immediate medical attention should be sought. If a child has consumed the recalled formula but is not showing symptoms, caregivers should continue to monitor them closely and seek medical attention if symptoms develop.

Laboratory analyses have indicated that ByHeart Whole Nutrition infant formula is the source of this outbreak. In January 2026, the FDA announced that two samples of ByHeart powdered infant formula tested positive for Clostridium botulinum (toxin), Type A. These samples were found to match a clinical isolate from an infant involved in the outbreak through whole genome sequencing. Further analysis revealed that these positive results also matched two isolates of organic whole milk powder, an ingredient used by ByHeart in its infant formula production. One of these organic whole milk powder samples was collected by the FDA at a processor for a ByHeart supplier. The investigation is continuing to pinpoint the exact source of contamination.

ByHeart previously reported in December 2025 that six out of 36 tested finished product samples were positive for Clostridium botulinum. These samples were from batches identified in the initial product recall. The detection of Clostridium botulinum in infant formula is a complex process, requiring specialized testing and laboratory equipment due to the heat-resistant nature of its spores. This complexity, coupled with a limited number of labs equipped for such testing, can lead to confirmation delays of several weeks.

The recall of all ByHeart infant formula products encompasses all cans and single-serve “anywhere pack” sticks. Despite the recall, the FDA has received reports that recalled products are still being found on store shelves nationwide, as well as through online marketplaces. The FDA is working with state partners and retailers to ensure the effective removal of these products from the market. ByHeart infant formula represents approximately 1% of all infant formula sold in the United States, and this recall is not expected to cause a shortage of infant formula for parents and caregivers.

The recalled product was also distributed internationally to countries including Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and the British Virgin Islands. Consumers worldwide are urged not to use any ByHeart brand infant formula.

In addition to product safety concerns, the FDA has released inspection reports from ByHeart manufacturing facilities. Inspections conducted between 2022 and March 2025 at three Blendhouse manufacturing facilities revealed some deficiencies. The Allerton, Iowa facility was cited for Good Manufacturing Practice (GMP) deficiencies in its February 2025 inspection, and the Reading, Pennsylvania facility was cited for Official Action Indicated (OAI) GMP deficiencies in its January 2024 inspection, with that facility having ceased operations in September 2023. The Portland, Oregon facility’s March 2025 inspection resulted in a No Action Indicated (NAI) classification.

Parents and caregivers are advised to wash any items and surfaces that may have come into contact with the recalled formula using hot, soapy water or a dishwasher. Physicians who suspect an infant patient has botulism are instructed to immediately call the CDPH clinical support line at 510-231-7600 for case consultation, which is available 24/7.

Article by Mel Anara, based upon information from the U.S. Food and Drug Administration

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