Federal health officials warn that infant formula linked to a botulism outbreak may still be available in stores despite a voluntary recall. The Food and Drug Administration (FDA) reported 31 suspected or confirmed cases of infant botulism in babies who consumed ByHeart Whole Nutrition formula and became ill between August and mid‑November. All 31 infants were hospitalized; no deaths have been reported. Infant botulism can cause a life‑threatening, progressive paralysis in babies younger than one year.
The FDA says epidemiologic and laboratory evidence indicates ByHeart Whole Nutrition formula might be contaminated with Clostridium botulinum, the bacterium that causes infant botulism. ByHeart first recalled two production 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 formula was sold online and at major retailers such as Target, Publix, Walmart and Whole Foods, and some shipments went overseas. ByHeart’s products make up roughly 1% of U.S. infant formula sales, so the FDA does not expect the recall to cause a broad formula shortage.
Investigations and testing
The FDA’s cases involve babies in 15 states: Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The agency broadened its probe after first flagging a cluster of infant botulism cases on Nov. 8. At that point, officials said 13 of an estimated 83 infant botulism cases reported nationally 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. California’s Department of Public Health tested an opened can and detected C. botulinum; ByHeart initially cautioned that an opened can alone did not prove the source because the bacterium can be found in environmental materials such as soil and dust. The company later said third‑party testing identified the bacterium in some samples of unopened formula as well. After additional reported cases, ByHeart expanded the recall to include all products and issued guidance for parents switching formulas.
Retail availability and FDA response
The FDA has asked retailers to remove the recalled products, but the agency said it has received reports of recalled formula still appearing on store shelves in multiple states. The FDA is coordinating with state partners and retailers to try to ensure the recall is carried out effectively.
Symptoms, treatment and guidance for parents
Infant botulism occurs when a baby ingests spores of C. botulinum that germinate and produce toxin in the gut. Symptoms usually emerge three to 30 days after exposure and often begin with constipation, poor feeding, difficulty swallowing and loss of head control. If untreated, babies can develop progressive, flaccid paralysis that may impair breathing and require extended hospitalization.
Treatment involves an antitoxin known as BabyBIG, administered intravenously. The Centers for Disease Control and Prevention (CDC) advises parents to monitor infants for several weeks after their last consumption of ByHeart formula. Parents are urged to wash potentially contaminated surfaces, label any leftover powder “DO NOT USE,” and store it safely for up to a month in case public health authorities need to test it. The California Department of Public Health has established an infant botulism outbreak hotline for concerned parents, and the CDC recommends seeking immediate medical care for worrisome symptoms.
ByHeart’s response
ByHeart, which launched in 2022 and markets itself as a next‑generation baby nutrition company, says it is cooperating with the FDA and conducting extensive testing to determine the contamination source. The company has given regulators access to its facilities and products, set up a 24/7 customer support line, and offered refunds for purchases made since October. ByHeart also says it will implement additional safeguards and testing; it noted that C. botulinum was not routinely tested for across the industry until now.
Legal action
Several affected families have filed lawsuits. Parents of two four‑month‑old infants hospitalized with botulism in Arizona and Kentucky filed separate federal negligence suits seeking compensation for medical costs and emotional distress. A class‑action complaint filed in New York accuses ByHeart of deceptive marketing. ByHeart declined to comment on pending litigation but reiterated its commitment to supporting families and cooperating with the FDA’s investigation.
What parents should do
– Stop using any ByHeart formula and check purchase records and receipts.
– Watch infants closely for symptoms for several weeks after the last known exposure.
– If you have leftover powder, label it “DO NOT USE,” keep it secure, and retain it for possible testing by health authorities.
– Clean surfaces that may have been contaminated and seek immediate medical care if your baby shows concerning symptoms.
Public health agencies continue to investigate and are working with retailers and the manufacturer to remove recalled product from circulation and to identify the contamination source.