Baby boy battles infant botulism after ByHeart formula donated to family

“I accepted it thinking, ‘OK, I’m hoping my baby can get on a bottle,'" Carter said. “It’s been all downhill since then.”

State officials wouldn’t comment on Carter’s case, but they acknowledged that the agency received ByHeart formula from PDX Diaper Bank. That was one of nearly two dozen nonprofit groups nationwide who are part of ByHeart’s “OpenHearted Initiative” that donated formula to “families in need,” according to the company’s website.

Since June 2022, nearly 24,000 cans of formula have been distributed to groups that aid homeless and other vulnerable families, the company said. All the company's products have been recalled since production began in March 2022 because of potential contamination.

Soon after consuming the ByHeart formula, Ashaan developed severe constipation and muscle weakness, becoming so limp that he couldn’t move his head, Carter said.

After a trip to an emergency room, he was sent to Randall Children’s Hospital in Portland. Doctors there diagnosed him with presumed infant botulism tied to the ByHeart formula, according to Dr. Sylvia Peterson-Perry, a family medicine doctor who delivered Ashaan and cares for him and his mother.

He was treated with BabyBIG, an IV medication that provides antibodies to the infection to stop the progress of the disease.

Ashaan was hospitalized for nearly two weeks in November and discharged without a feeding tube. His health rapidly declined, including dramatic weight loss, and he was hospitalized again in December. He got so sick that his mother was afraid he would die.

“He was just withering away,” Carter said.

The Oregon caseworker texted Carter after the recall, she said, warning her to stop using the formula.

But it was too late for Ashaan, who had to have the feeding tube down his throat replaced because his muscles remain weak, his doctor said. It's not clear how long it will remain. He is having to relearn how to crawl and to talk.

“It’s devastating, especially for our vulnerable families who are trusting this product to nourish their child and trusting our social services to provide safe food for their babies,” Peterson-Perry said.

ByHeart had partnered with Baby2Baby, a Los Angeles-based nonprofit that includes high-profile celebrities among its supporters. The news outlet Healthbeat was first to report that recalled formula went to groups serving at-risk families.

PDX Diaper Bank received about 400 cans of donated ByHeart formula through Baby2Baby and distributed more than 300 of them before they were recalled, Rachel Alston, the group’s executive director, said in an email.

“All of our partners confirmed that they took immediate action to inform families, and we offered support where we could along the way,” she said in an email.

Baby2Baby officials did not respond to email requests for comment. ByHeart officials said the company worked with Baby2Baby and other groups that received formula to ensure that the products were pulled and families were notified.

No new cases of infant botulism tied to the outbreak have been reported since Dec. 17, according to the U.S. Centers for Disease Control and Prevention. The U.S. Food and Drug Administration has conducted inspections at ByHeart plants, but has released no information about the source of the outbreak. Production remains shut down.

Seattle food safety lawyer Bill Marler said Carter is one of more than 30 families he represents whose babies were sickened by ByHeart products. At least 18 lawsuits have been filed against ByHeart and stores that sold the contaminated formula. This week, Marler asked a federal panel to consolidate the cases in a U.S. district court in New York.