Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington reported cases.
Food and Drug Administration (FDA) officials are investigating 13 cases of infant botulism in 10 states connected to a brand of baby formula that is now under recall.
In a statement released on the FDA’s website on Nov. 8, ByHeart Inc. agreed to start recalling two lots of the company’s Whole Nutrition Infant Formula.
No deaths from the illness were reported in the states where the cases of infant botulism were detected. The states are Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, according to a separate statement by the FDA.
“Officials in several states have collected leftover infant formula for testing,” the agency said on Nov. 8. “This testing is underway, and results are not yet available but expected in the coming weeks.”
Two lots of ByHeart Whole Nutrition Infant formula were recalled after the cases were reported. The lots are 206VABP/251261P2 and 206VABP/251131P2, according to the recall statement.
Products from those two lots “were reported to have been consumed by the infants,” the statement said.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” Mia Funt, the president of ByHeart, said in a statement. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise.”
Funt said that the formula was recalled “out of an abundance of caution and comes from [ByHeart’s] ongoing commitment to transparency and safety” for consumers.
“While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product,” she said, “we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
The FDA said it is working to ensure that all products that may be affected are removed from the market.
Sold online and through major retailers, the product accounts for an estimated 1 percent 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 the product out or returning it where it was purchased, the CDC said in a statement on Nov. 8.
Consumers are advised to use a dishwasher or hot, soapy water to clean items and surfaces that touched the formula. They should seek medical care right away if an infant has consumed recalled formula and then had poor feeding, loss of head control, difficulty swallowing, or decreased facial expression.
Infant botulism is caused by a bacterium that produces toxins in the large intestine. Symptoms can take weeks to develop, so parents should stay vigilant, the CDC stated.
Other symptoms of infant botulism include drooping eyelids, weaker crying, constipation, a lack of facial expression, and choking while trying to feed, according to the Cleveland Clinic.
The clinic also stated that infant botulism usually occurs in babies under 1 year of age, and about 95 percent of cases occur in babies younger than 6 months.