ByHeart Infant Formula Recall Expands Amid Botulism Outbreak

Federal health officials have expanded the recall of ByHeart infant formula to include all products produced since March 2022, following a botulism outbreak affecting at least 51 infants across 19 states. The U.S. Food and Drug Administration (FDA) stated that investigators "cannot rule out the possibility that contamination might have affected all ByHeart formula products" ever made.

The Centers for Disease Control and Prevention (CDC) updated the case definition to include "any infant with botulism who was exposed to ByHeart formula at any time since the product's release." The most recent illness was reported on December 1.

ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on November 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling approximately 200,000 cans of the product each month.

Laboratory tests detected Clostridium botulinum type A in multiple batches of ByHeart formula. The FDA sent inspectors to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.

Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It's caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression.

The sole treatment for infant botulism is known as BabyBIG, an intravenous medication made from the pooled blood plasma of adults immunized against botulism. California's infant botulism program developed the product and is the sole source worldwide.

Families of several babies treated for botulism after drinking ByHeart formula have filed lawsuits against the company. The lawsuits allege that the formula they fed their children was defective and that ByHeart was negligent in selling it. They seek financial compensation for medical bills, emotional distress, and other harm.