Infant formula tied to a botulism outbreak that has sickened dozens of babies across 15 states may still be on store shelves despite a recall, federal health officials say.
As of Wednesday, the Food and Drug Administration (FDA) reported 31 suspected or confirmed cases of infant botulism in babies who consumed ByHeart Whole Nutrition formula and fell ill between August and mid-November. No deaths have been reported, but all 31 infants were hospitalized. Infant botulism can cause a life-threatening, progressive paralysis in babies under one year old.
The FDA said epidemiologic and laboratory data indicate ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, the bacterium that causes infant botulism. ByHeart initially recalled two batches earlier this month and then expanded the voluntary recall to all of its products — including canned formulas and single-serve packets — last week. The products were sold online and at major retailers such as Target, Publix, Walmart and Whole Foods, and some were shipped internationally. ByHeart’s products account for roughly 1% of U.S. infant formula sales, so the FDA said it does not expect a broader formula shortage.
ByHeart, a company that entered the market in 2022 and describes itself as a “next‑generation baby nutrition company,” said it is cooperating with the FDA and investigating its processes to determine the source of contamination. The company and the FDA have urged adults to stop using the formula and to monitor infants for botulism symptoms. The FDA also asked retailers to stop selling the product, but the agency said it has received reports of recalled formula still being found on store shelves in multiple states. The FDA is working with state partners and retailers to ensure an effective recall.
What we know about the outbreak
The FDA’s cases span 15 states: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The agency’s investigation expanded after it first announced scrutiny of infant botulism cases on Nov. 8; at that time, 13 of an estimated 83 infant botulism cases reported nationwide since August had consumed ByHeart formula.
Botulism is rare in dairy products, and the FDA noted there is no historical precedent for infant formula causing infant botulism. After the initial recall of two batches, California’s Department of Public Health tested a sample from one opened can and found Clostridium botulinum. ByHeart initially cautioned that the opened can did not conclusively link the product to the outbreak because the bacterium can occur in environmental sources like soil and dust. However, ByHeart later said third‑party testing found the bacteria in some samples of unopened formula as well. Following additional cases the FDA identified, ByHeart recalled all its products and provided guidance to parents on switching formulas.
What to know about infant botulism
Infant botulism occurs when a baby ingests spores of C. botulinum, which can germinate and produce toxin in the gut. Symptoms typically appear three to 30 days after exposure and often begin with constipation, poor feeding, difficulty swallowing and loss of head control. If untreated, infants can develop progressive flaccid paralysis that may cause breathing difficulties and require prolonged hospitalization.
Treatment involves administration of an antitoxin known as BabyBIG, given intravenously. The Centers for Disease Control and Prevention (CDC) advises parents to remain vigilant for several weeks after their baby last consumed ByHeart formula. Parents are instructed to wash contaminated surfaces, label any leftover powder “DO NOT USE,” and store it safely for a month in case health departments want to test it. The CDC also directs concerned parents to an infant botulism outbreak hotline set up by the California Department of Public Health and urges immediate medical attention for worrisome symptoms.
What the company is doing
ByHeart says it is conducting extensive testing and has given the FDA complete access to its facilities and products. The company has provided resources to customers since the recall, including a 24/7 support hotline and refunds for purchases made since October. ByHeart has pledged to implement stronger safeguards and additional testing going forward, noting that C. botulinum was not among pathogens routinely tested across the industry until now.
Legal action
Several families affected by the outbreak have pursued legal action. The parents of two four‑month‑old infants hospitalized with botulism in Arizona and Kentucky filed separate federal lawsuits last week alleging negligence and seeking compensation for medical costs and emotional distress. A class-action lawsuit filed in New York accuses ByHeart of deceptive marketing. ByHeart declined to comment on litigation but reiterated its commitment to supporting families and cooperating with the FDA’s investigation.