Baby formula tied to botulism outbreak could have been in American stores since 2022 as massive recall continues

The infant botulism outbreak tied to ByHeart formula has grown, and federal regulators now say all their products could have been contaminated since their launch in March 2022.

An additional 10 cases of infant botulism from December 2023 through July 2025 are now included in the investigation into the outbreak, the CDC announced Wednesday.

The FDA added it “cannot rule out the possibility that contamination might have affected all ByHeart 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 involves at least 51 cases across 19 states, with illnesses traced back to December 2023, according to the FDA update Wednesday. Ages range from infants between 16 and 264 days, with no reported deaths.

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 the Associated Press that their children became sick earlier after consuming ByHeart formula. Texas and California had seen the most cases at the time.

On November 11, ByHeart recalled all of its products. The recall applies to every lot number and all sizes of its formula, including both cans and single-serve packets, according to the CDC.

ByHeart Whole Nutrition Infant Formula was sold online and at major retailers across the United States. Families and caregivers should stop using the products immediately.

Infant botulism is a rare disease affecting fewer than 200 U.S. babies annually, and is caused when botulism bacteria produce toxins in an infant’s intestines. Babies under 1 are most vulnerable due to immature gut microbiomes.

Symptoms, which can take up to 30 days to appear, include constipation, poor feeding, floppy limbs, drooping eyelids, and breathing or swallowing difficulties.

The only treatment is BabyBIG, an IV medication made from plasma of immunized adults, developed by California’s infant botulism program and the sole source worldwide. Its antibodies are most effective for about a month but may persist longer in the child’s system.

If you suspect your baby is showing any signs of infant botulism, seek medical care immediately.

As of November 22, at least four families whose babies developed botulism after consuming ByHeart formula have sued the company, alleging the product was defective and that ByHeart was negligent, seeking compensation for medical costs, emotional distress and other damages, NBC News reported.