PORTLAND — ByHeart and the Food and Drug Administration issued a nationwide recall of all ByHeart infant formula products on Nov. 11. The recall followed an FDA investigation that found Clostridium botulinum in a powdered milk ingredient used in the formula.

This recall marked the first botulinum toxin outbreak associated with baby formula. Forty-eight babies in 17 states were hospitalized with confirmed or suspected botulism linked to ByHeart formula. No deaths were reported in the outbreak, which the FDA declared over in February.

An Oregon Department of Human Services caseworker suggested Portland resident Angel Carter use ByHeart infant formula. Carter recalled the caseworker stating the formula was "the closest thing to breast milk." Within a week of consuming the formula, Carter's son, Ashaan, stopped making eye contact and stared into space for 30 minutes or longer. He also lost interest in food, stopped nursing, and lost the strength to sit upright during that week.

"He was turning grayish blue. He looked like a faded picture of himself," Carter stated. She added, "His eyes rolled into the back of his head, and I was like, 'Oh my God, my baby is dying.'" Doctors informed Carter that Ashaan could die without proper medical intervention. Ashaan, who turned one in February, has a gastrostomy tube surgically implanted for supplemental nutrition. Carter said, "He's just now to the point where he will suckle on something until it melts in his mouth enough for him to swallow it."

Myra Brooks, an epidemic service intelligence officer with the CDC, reviewed medical records for 46 of the 48 babies involved in the ByHeart outbreak. None of the 46 babies reviewed had a fever. Problems with the sucking reflex were present in 91% of these babies, and 87% were constipated.

Darin Detwiler, a food policy professor at Northeastern University, stated in an email, "We are no longer talking about a single event. We are talking about a pattern." Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children's Hospital in New York, stated, "I don't want families to think that this is something we expect to see in all powder formulas. But to have two outbreaks come so close to each other with the same pathogen is quite worrisome." ByHeart and Nara Organics stated they are cooperating with health officials. Products from ByHeart and Nara Organics account for about 1% of the U.S. formula market, according to the FDA.