The Centers for Disease Control (CDC) and the Food and Drug Administration  (FDA) are investigating 13 reported cases of infant botulism and hospitalisations 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 hospitalisation, according to the CDC.

Although it can be fatal, there are treatments for the toxin. There are no reported deaths of this specific outbreak.

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.

Representatives of ByHeart didn’t respond to requests for comment.