An urgent baby formula recall is underway after federal health officials connected ByHeart Whole Nutrition Infant Formula to a growing infant botulism outbreak affecting 10 states.
The FDA reported that 13 babies have been hospitalized since August after consuming the formula. Although no deaths have been reported, the risk remains serious.
The affected product includes two lots with December 1 “use by” dates, labeled 206VABP/251261P2 and 206VABP/251131P2. Parents are urged to check the packaging and discard the product immediately.
Infant botulism, a potentially deadly condition caused by bacterial toxins, can lead to symptoms such as constipation, difficulty swallowing, and muscle paralysis.
“ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants,” the company said in a statement. “The FDA has not identified a direct link between any infant formula and these cases, and there is no historical precedent of infant formula causing infant botulism.”
Preliminary tests from California public health officials detected the presence of the bacteria in a can of the formula consumed by one affected infant.
ByHeart formula, which uses organic, grass-fed whole milk, is sold in nearly 12,000 stores but represents less than 1% of U.S. formula sales.
Parents who recently used the ByHeart formula should closely monitor their child’s health, as symptoms may take weeks to appear.
