San Diego County health officials sounded the alarm on December 4, 2025, urging parents and retailers to immediately discard ByHeart Whole Nutrition Infant Formula after the product was linked to a nationwide outbreak of infant botulism. While the recall began in early November, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have since confirmed that 39 infants across 18 states have been hospitalized with the rare but potentially deadly illness, with cases reported in states as far-flung as California, Texas, Massachusetts, and Pennsylvania.
According to Times of San Diego, no cases have been reported in San Diego County as of the warning, but the urgency was clear: parents were told to check their homes for any remaining ByHeart formula and discard it immediately. "It is really important that parents and caregivers check their baby’s formula and stop using any ByHeart formula products immediately," said County Public Health Officer Dr. Sayone Thihalolipavan. The warning comes amid ongoing concerns that, despite the recall, some ByHeart formula was still being found on store shelves at major retailers including Walmart, Target, Kroger, Acme, and Shaw’s.
The outbreak first came to light in early November, when the FDA issued an initial advisory about the contaminated formula. ByHeart, an organic infant formula manufacturer, responded with a voluntary nationwide recall of all cans and single-serve "anywhere pack" sticks on November 11, 2025. The company acknowledged the contamination on its website and promised to replace discarded cans at no cost. However, as The Independent reported, the recall’s effectiveness has been undercut by the discovery that some stores continued to stock the product weeks after the alert.
State and federal officials have scrambled to remove the formula from circulation. In Pennsylvania, the Department of Agriculture conducted emergency inspections at 11 retailers in Lehigh and Northampton counties, including several Target, Walmart, and Wegmans locations. None of the stores were found to have the recalled formula on their shelves at the time of inspection, but the FDA has stressed that the risk remains in other areas. "FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country," the agency said. The FDA continues to urge vigilance, warning that "all ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online."
The CDC and FDA have traced the outbreak back to August 2025, with the first reported case identified on August 9. The illness, infant botulism, is caused by ingesting spores of Clostridium botulinum, which can grow in a baby’s gut and produce a dangerous toxin. As Lehigh Valley News explained, symptoms can appear anywhere from three to 30 days after consumption. These include constipation, poor feeding, weak or altered crying, loss of head control, muscle weakness, difficulty swallowing, drooping eyelids, lethargy, decreased facial expression, and in severe cases, respiratory difficulties or even respiratory arrest. The American Academy of Pediatrics advises that if a child who consumed ByHeart formula develops any of these symptoms, parents should seek medical attention immediately.
Dr. Chas Hannum, a pediatrician at Tufts Medical Center, emphasized to Boston 25 News just how serious the illness can be. "Infant botulism is thankfully quite rare but can be really severe. A lot of babies with infant botulism that is severe will need to be in the hospital. Often times it will need to be intubated and using a breathing machine to keep them alive. That can last for weeks and sometimes even months." While there are medications available in hospitals, there is no outright cure for botulism; most infants must endure the symptoms with supportive care.
Despite the recall, the FDA has continued to receive reports of ByHeart formula being found on store shelves across multiple states. The agency has been working with state and local partners to ensure the product is removed, but the persistence of the formula in retail outlets has fueled frustration among affected families. At least four families have filed lawsuits against ByHeart, claiming their babies were sickened by the contaminated formula. Stephen Dexter of Arizona, whose four-month-old daughter Rose spent weeks in the hospital, told the Associated Press, "I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe." Similarly, Hanna Everett of Kentucky, whose daughter Piper was also hospitalized, expressed her anguish: "She’s so little and you’re just helplessly watching this."
In Massachusetts, two infants have been diagnosed with botulism linked to the outbreak, according to the CDC. The Massachusetts Department of Health did not disclose further details, but the emergence of cases in the state has heightened concern. The FDA reiterated its advice: "Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product." For those who have already discarded the formula, ByHeart has pledged to replace the cans at no cost. Parents are also advised to photograph or record information from the package, label it "DO NOT USE," and store it for 30 days in case health officials need to test the product.
In California, Texas, and Pennsylvania—three of the states hardest hit by the outbreak—health officials have been especially vocal. California and Texas, the two most populous states, have seen the most cases, according to the CDC. In Pennsylvania, one to two cases have been reported, with all affected children hospitalized. Laboratory confirmation for some cases is still ongoing. As of December 4, 2025, there have been no reported deaths, but the risk of severe complications remains high. The FDA warns that botulism can be fatal if not treated promptly.
For parents and caregivers, the guidance is unequivocal: stop using ByHeart formula immediately, check for symptoms, and seek medical attention if there are any concerns. The FDA also recommends cleaning any surfaces or items that may have come into contact with the product. If infants do not develop symptoms within 30 days of consuming the formula, containers should be thrown out. Additionally, parents can report product problems through the FDA’s SmartHub or by completing a voluntary MedWatch form.
ByHeart has updated its refund policy to provide a full refund for all products purchased on its website on or after August 1. Consumers who bought the formula through retail partners like Amazon or Target are advised to contact those retailers directly for refunds.
The botulism outbreak has shaken trust in infant formula safety and prompted calls for stricter oversight and faster recall processes. As one Washington state mother, Madison Wescott, told NBC News, "Knowing that I can’t fully feed my child, and I can’t trust formula companies has really taken a toll on our family." For now, health officials across the country hope that increased awareness and swift action will prevent further cases and protect the most vulnerable.
