November 19, 2025

The infant botulism outbreak linked to consumption of powdered infant formula has expanded to encompass 15 states, according to an update released today by the CDC.

Confirmed and suspect cases now total 31 infants. All of the victims have been hospitalized and treated with the BabyBIG® antitoxin. There have been no deaths.

Infant botulism occurs when a baby ingests spores of Clostridium botulinum and those spores germinate in the intestine and produce toxin.

Cases have been reported in Arizona (3), California (4), Idaho (1), Illinois (2), Kentucky (1), Maine (1), Michigan (1), Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (6), and Washington (2).

Epidemiology and lab data appear to link the illnesses to ByHeart Whole Nutrition powdered infant formula, according to the CDC.

ByHeart Inc. has recalled all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™. The recalled products were sold online and through major retailers across the USA.

ByHeart infant formula represents  approximately 1% of all infant formula sold in the USA, according to the FDA.

What caregivers need to know (per CDC)

• Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
  • If possible, take a picture or record the lot number and best by date.
  • If you have leftover ByHeart powdered formula, label it “DO NOT USE” and keep it stored in a safe place for at least a month.
  • If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
• Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.

• Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
  • Poor feeding
  • Loss of head control
  • Difficulty swallowing
  • Decreased facial expression
• Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
• California Department of Public Health has a public hotline to support caregivers with concerns about this outbreak and infant botulism.
  • Available Monday to Sunday, 7 a.m. to 11 p.m. Pacific Standard Time
  • 1-833-398-2022

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