The US Food and Drug Administration is investigating a multistate outbreak of infant botulism and has advised parents to avoid certain lots of ByHeart Whole Nutrition Infant Formula.
In a statement on Saturday, the agency urged parents and carers to dispose of the formula immediately and seek medical attention if their infants show symptoms of botulism, which can include constipation, poor feeding, loss of head control, difficulty swallowing, and respiratory problems.
The outbreak has affected 13 infants across 10 states, including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, with no deaths reported so far.
ByHeart, the formula’s manufacturer, announced a voluntary recall of the two batches, stating that the decision was made “out of an abundance of caution” after being notified by the FDA.
The company said there is no direct evidence that its formula caused the illnesses and that botulism is extremely rare in dairy products or infant formula.
Available online and through major retailers, the product accounted for an estimated 1% of national formula sales, according to the Centers for Disease Control and Prevention (CDC).
People who bought the recalled formula should record the lot number if possible before throwing it out or returning it to where it was purchased, the CDC said in a statement. They should use a dishwasher or hot, soapy water to clean items and surfaces that touched the formula.
Infant botulism is caused by a bacterium that produces toxins in the large intestine. Symptoms can take weeks to develop, so parents should remain vigilant, the CDC said.
