Baby Formula Recalled After Infant Botulism Outbreak

Baby formula manufacturer ByHeart Inc. agreed to recall some of its powdered formula after 13 infants were diagnosed with botulism after consuming the product.

The Centers for Disease Control and the FDA are investigating 13 reported cases of infant botulism and hospitalizations in 10 states. All the babies affected had consumed ByHeart brand powdered infant formula.

Infant botulism can lead to breathing difficulties and muscle paralysis and require weeks of hospitalization, according to the CDC. Although it can be fatal, there are treatments for the toxin. There are no reported deaths of this specific outbreak.

Infant botulism outbreak: 13 infants sick in 10 states; no deaths. ByHeart infant formula recalled. Seek medical care right away for poor feeding, loss of head control, difficult swallowing, decreased facial expression. Symptoms can take as long as several weeks to develop. pic.twitter.com/7IlDvWaJad

— Deputy Secretary Jim O’Neill (@HHS_Jim) November 8, 2025

FDA and CDC Officials said they are testing leftover formula to investigate the origin of the contamination. ByHeart agreed to recall two lots of the formula that are suspected to be contaminated.

“While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants,” Mia Funt, ByHeart’s co-founder and president said in a statement.

The ByHeart formula is advertised as being the “closest-to-breast-milk patented protein blend and made with organic, grass-fed whole milk,” per their website.

Infant botulism cases linked to this outbreak have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, the FDA said.

The recall includes two lots of the powdered formula by the lot codes 206VABP/251261P2 and 206VABP/251131P2.