U.S. infant formula recall expanded amid widening infant botulism outbreak


  • World
  • Wednesday, 12 Nov 2025

LOS ANGELES, Nov. 11 (Xinhua) -- The recall of ByHeart Whole Nutrition infant formula in the United States has been expanded to include all products, as infant botulism cases continued to rise across multiple states, according to the U.S. Centers for Disease Control and Prevention (CDC).

As of Monday, 15 infants with suspected or confirmed infant botulism had been reported from 12 states, according to an update from the CDC's official website, while laboratory confirmation is still underway for several cases.

Among the 14 cases with illness onset information available, symptoms began between Aug. 9 and Nov. 10, said the CDC, adding that all 15 infants were hospitalized and treated with BabyBIG, an intravenous medication used for infant botulism, with no deaths reported.

For the 14 infants with age and sex information available, the CDC said that patients ranged from 16 days to 157 days old, and half were female.

ByHeart initially recalled two lots of its Whole Nutrition infant formula on Nov. 8. However, the CDC and the U.S. Food and Drug Administration (FDA) warned that additional lots may also be contaminated and linked to ongoing illnesses.

On Tuesday, the company expanded its recall to all ByHeart Whole Nutrition infant formula products, including all unexpired lots of formula cans and single-serve sticks.

The CDC and FDA urged parents and caregivers to stop using any ByHeart infant formula products immediately.

According to the CDC, symptoms of infant botulism often include constipation, poor feeding, loss of head control, and difficulty swallowing, and may take several weeks to appear after ingestion of contaminated formula.

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