ByHeart Formula Botulism Outbreak Has Hospitalized 31 Infants Nationwide: CDC

Multi-state outbreak of botulism has led to a recall of all lots of ByHeart Infant Formula, which may still be found on some store shelves or U.S. homes.

More than 31 infants have been hospitalized in connection with a ByHeart Infant Formula botulism outbreak, which has spread across 15 states in recent weeks.

The U.S. Centers for Disease Control and Prevention (CDC) issued an infant botulism outbreak update on November 21, stating that all infants affected in the botulism outbreak have required hospitalization, with the youngest patient just 16 days old.

Infant botulism is an uncommon illness that develops when Clostridium botulinum spores are ingested and begin producing toxin in a baby’s gut. Early signs often include constipation, difficulty feeding, a weak or altered cry and poor head control. Other symptoms may involve trouble swallowing and reduced facial expression. Because the condition develops gradually, symptoms may take weeks to appear.

Without treatment, the illness can progress to paralysis and lead to serious breathing difficulties that may require prolonged hospitalization. In severe cases, infant botulism can be fatal.

ByHeart Infant Formula Recall

The ByHeart Infant Formula recall was first issued on November 8, after health officials connected 13 infant botulism illnesses with the contaminated ByHeart brand infant formula. Out of caution, ByHeart recalled two batches of their Whole Nutrition Infant Formula.

However, following the initial recall, the outbreak continued to spread, with more infants becoming ill in the following weeks. As a result, the ByHeart Infant Formula recall has been expanded to include all lots of ByHeart Whole Nutrition Infant Formula and single serve packets that are for sale across the U.S., internationally and online.

While no deaths have been reported in connection with the outbreak, at least 31 cases of infant botulism have been reported in the following 15 states, with the majority of cases having occurred in Texas:

Despite the risks associated with the recalled formula, the U.S. Food and Drug Administration (FDA) reports that ByHeart Infant Formula is still being found in some stores nationwide, including Walmart, Target and Kroger. In addition, previously purchased products may still remain in the homes of families nationwide, unaware of the hidden risks posed by the formula.

Parents and caregivers are being advised to immediately stop using ByHeart Infant Formula. If a child has already been fed ByHeart Infant Formula and is experiencing symptoms, immediate medical attention should be sought.

The investigation now includes the CDC, FDA, and the California Department of Public Health’s Infant Botulism Treatment and Prevention Program. Federal officials indicate the outbreak should not impact the national formula supply, noting that ByHeart represents roughly 1% of U.S. infant formula sales.

ByHeart Botulism Outbreak Lawsuits

Following the CDC announcement of the ByHeart Infant Formula botulism outbreak, multiple lawsuits have been brought nationwide.

In one of the first cases, a Kentucky couple filed a lawsuit on November 18, alleging that ByHeart Infant Formula was the source of their 4-month-old daughter’s botulism illness. 

Days later, the manufacturers were named in a ByHeart infant formula class action lawsuit alleging ties to the botulism outbreak. The action seeks relief for families who purchased tainted batches of ByHeart Infant Formula.

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