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Infant Formula Recall Issued Due to Botulism Outbreak in Multiple States

Infant Botulism Outbreak Triggers Nationwide Formula Recall

A concerning outbreak of infant botulism has led to a nationwide recall of ByHeart Inc. Whole Nutrition Infant Formula, affecting parents and caregivers across multiple states. The North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture and Consumer Services have issued a joint alert regarding this serious health issue.

According to the U.S. Food and Drug Administration, as of November 10, there have been 15 reported cases of suspected or confirmed infant botulism linked to the ByHeart Whole Nutrition Infant Formula across 12 states. North Carolina is currently investigating one such case.

By November 11, all batches of the formula had been voluntarily recalled as investigations continue. Parents are advised to check their home supplies as the product, although removed from store shelves, remains easily accessible online.

ByHeart Inc. Whole Nutrition Infant Formula

Agriculture Commissioner Steve Troxler stated, “Our Food and Drug Protection Division is working with counterparts at the Food and Drug Administration and NCDHHS on this recall. Our Food and Drug Protection Division is also working with retailers to make sure they have been notified about the recalled product and are removing it from store shelves.” He emphasized the need for parents to ensure the formula is not in use at home.

Botulism, a rare but severe paralytic illness, is caused by a toxin from the bacteria Clostridium botulinum. All forms of this illness are medical emergencies and can be fatal. More information can be found on the NCDHHS website.

The NCDHHS has issued a memo to healthcare providers to remain vigilant for infants displaying symptoms of botulism. Dr. Kelly Kimple, Director of the NCDHHS Division of Public Health, highlighted the gravity of the situation, saying, “Infant botulism is a serious illness and can be life-threatening. NCDHHS is working with our public health and healthcare partners to be sure parents are not using the recalled formula so more babies in North Carolina won’t be exposed.”

Parents who have purchased the affected formula should not use it. Instead, they should discard it or return it to the place of purchase. Cleaning items and surfaces that have come in contact with the formula is also advised. Recording the lot number or photographing the product before disposal is recommended.

Symptoms of infant botulism may take several weeks to manifest. Parents should seek immediate medical attention if their infant, who consumed the formula, exhibits symptoms such as:

  • Poor feeding
  • Difficulty swallowing
  • Decreased facial expression
  • Loss of head control
  • Respiratory difficulty

ByHeart Inc. Whole Nutrition Infant Formula comprises approximately 1% of national infant formula sales, and the recall is not expected to result in shortages. It is not a SNAP/WIC eligible product, and numerous alternatives are available for caregivers.

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