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infant botulism outbreak tied to bayheart FORMULA has increased, and federal regulators now say all of their products may be contaminated after they launch in March 2022.
10 additional cases of infant botulism from December 2023 to July 2025 now included Investigation In the outbreak, the CDC announced Wednesday.
fda couple This possibility cannot be ruled out contamination This may have affected all Bayheart formula products ever made. Therefore, health officials expanded the outbreak to cover all illnesses reported since the company began production in March 2022.
The outbreak now includes at least 51 cases in 19 states, with illnesses detected through December 2023, according to the FDA. update Wednesday. age range from babies Between days 16 and 264, no deaths were reported.
The latest case was reported on December 1, according to the CDC.
Officials previously reported 39 suspected or confirmed cases of infant botulism in 18 states since August 2025, but parents told associated Press That their children first became ill from drinking the Bayheart formula. At that time, the highest number of cases were seen in Texas and California.
On November 11, Bayheart recalled all of its products. According to the CDC, the recall applies to every lot number and all sizes of its formula, including both cans and single-serve packets.
BuyHeart Whole Nutrition Infant Formula was sold online and at major retailers throughout the United States. Families and caregivers should stop using the products immediately.
Infant botulism is a rare disease that affects fewer than one in 200 Americans. children per year, and it occurs when botulism bacteria produce a toxin in an infant’s intestines. Children under 1 year of age are most vulnerable due to their immature gut microbiome.
Symptoms, which can take up to 30 days to appear, include constipation, poor feeding, swollen limbs, droopy eyelids and difficulty breathing or swallowing.
The only treatment is BabyBIG, an IV drug made from plasma of immunized adults, developed by the Infant Botulism Program of California and its sole source worldwide. Its antibodies are most effective for about a month but can remain in the child’s system for longer.
If you suspect that your child is showing any symptoms of infant botulism, seek medical care immediately.
As of November 22, at least four families whose children developed botulism after taking the Bayheart formula have sued the company, alleging that the product was defective and that Bayheart was negligent, seeking compensation for medical costs, emotional distress, and other damages. nbc news Informed.