A baby nutrition company has voluntarily recalled two batches of infant formula following reports of an outbreak of botulism across 10 states. ByHeart issued the recall for “two batches of ByHeart Whole Nutrition Infant Formula” after being notified by the U.S. Food and Drug Administration (FDA) of a broader investigation into the cases. The CDC confirmed that 13 children have been hospitalized due to the outbreak.

The affected products include two lots of powdered formula with Dec. 1 “use by” dates, identified by lot numbers 206VABP/251261P2 and 206VABP/251131P2. The FDA urged parents and caregivers to check the packaging for identifying information and dispose of the product immediately. Retailers are also removing “all potentially impacted product” from shelves.

Infant botulism, caused by a bacteria-produced toxin, can lead to symptoms such as constipation, poor feeding, loss of head control, difficulty swallowing, and severe paralysis or death. The CDC emphasized that symptoms may take weeks to develop, advising caregivers to monitor children closely if they have consumed the formula.

The FDA stated it was investigating 13 cases of infant botulism across 10 states, with 13 infants having been exposed to ByHeart formula at some point. However, the agency noted no direct link between the formula and the cases, citing that botulism is extremely rare in dairy products or infant formula and typically originates from environmental sources like soil or dust.