ByHeart infant botulism cases level off

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Federal authorities are reducing the frequency of reporting on the infant botulism outbreak attributed to ByHeart powdered infant formula.

So far, the outbreak has sickened 51 babies in 19 states. All of the babies had to be hospitalized but none died. The Centers for Disease Control and Prevention has determined that some illnesses date back to December 2023. The outbreak was initially thought to have started in August of that year.

According to the Food and Drug Administration, reporting of illnesses linked to the outbreak has slowed since the last update on December 10. Therefore, the CDC will no longer issue weekly updates. Instead, the agency will only keep the public informed “when new information becomes available.”

As of November 11, all ByHeart products have been recalled. On December 12, the FDA sent letters to officials at Albertsons, Kroger, Target and Walmart warning them because they failed to promptly remove the recalled products from their store shelves and that such inaction was a violation of federal law.

The recalled ByHeart formula was available at other retailers and through online sales.

Testing by the California Department of Public Health, as well as ByHeart, found botulism in the company’s infant formula.

Sample collected/analyzed by

Product

Test result

Type of toxin

CDPH

ByHeart Baby Formula Open Container (Lot #251131P2)

Positive

Type A

By heart

ByHeart Infant Formula (undeclared lots)

Positive

Type A

By heart

ByHeart Infant Formula (undeclared lots)

Positive

Type A

By heart

ByHeart Infant Formula (undeclared lots)

Positive

Type A

By heart

ByHeart Infant Formula (undeclared lots)

Positive

Type A

By heart

ByHeart Infant Formula (undeclared lots)

Positive

Type A

Symptoms of Infant botulism

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which may progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which are diagnosed clinically, may take several weeks to develop after ingesting infant formula.

Any infant showing signs of botulism should be taken to a doctor or emergency room immediately.

Recommendations

  • Parents and guardians should immediately stop using ByHeart infant formula.
    • If your child has consumed ByHeart formula and has symptoms, seek medical attention immediately.
    • If your child has consumed ByHeart formula and is currently not experiencing any symptoms, continue to monitor them and seek medical attention if symptoms develop.
    • If you still have the formula at home, you must:
      • Take a photo or record the information at the bottom of the package.
      • Store the container in a safe place and be sure to label this product as DO NOT USE.
      • If your child develops symptoms, your state health department may want to collect your container of formula for testing. If your child does not develop any symptoms after 30 days, throw away your containers.
    • Parents and guardians in any state concerned about this outbreak and infant botulism can also contact the California Department of Public Health (CDPH) hotline at 833-398-2022. The hotline is available Monday through Friday from 7 a.m. to 7 p.m. PST.
    • Wash items and surfaces, containers and utensils who may have touched the formula using hot soapy water or a dishwasher.

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