ByHeart baby formula recalled

Federal health officials are investigating an outbreak of a rare infant disease in 10 states linked to baby formula that was being recalled, officials said.

At least 13 cases of infant botulism were recorded by Saturday following a recall of ByHeart Inc.’s Whole Nutrition Infant Formula, the Food and Drug Administration said in a statement.

Since August, at least 13 infants in 10 states who had been given the formula have had botulism type A infections, according to the F.D.A., which is investigating the outbreak with the Centers for Disease Control and Prevention and state and local health agencies, including California’s Infant Botulism Treatment and Prevention Program.

No deaths have been reported.

In a statement about the outbreak, the F.D.A. identified two lots of the infant formula, which is available online and at major retailers, that it said should not be used: 206VABP/251261P2 and 206VABP/251131P2.

The product is being tested, the agency said, and the results should be available in the next few weeks.

are displaying signs of botulism should immediately seek medical care.

Symptoms of botulism, which can be fatal, include poor feeding, loss of head control, difficulty swallowing and decreased facial expression. It can take several weeks after the formula is consumed before symptoms appear, according to the F.D.A.

The agency estimated that the formula represented less than 1 percent of all infant formula sold in the United States and said that the outbreak should not lead to formula shortages.

In 2022, infant formula had to be airlifted from Europe because of a nationwide shortage that was driven by the closure of a production plant over contamination concerns and lingering supply chain issues related to the coronavirus pandemic.

ByHeart, the maker of the formula identified by the F.D.A., said in a statement that it had initiated a voluntary recall of the two batches of its product.