(CNN) — The baby formula company ByHeart said Tuesday that it has recalled all of its infant formula products nationwide, including cans and single-serve sticks.

The US Food and Drug Administration and the US Centers for Disease Control and Prevention are investigating a multistate outbreak of infant botulism that may be tied to ByHeart’s “whole nutrition” infant formula products.

Epidemiologic and laboratory data has shown that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, the germ that causes botulism, the FDA said Tuesday.

According to the FDA, as of Monday, 15 children with suspected or confirmed infant botulism who had also been exposed to ByHeart infant formula have been reported in 12 states : Arizona, California, Illinois, Kentuc

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