A baby nutrition company has voluntarily recalled two batches of infant formula due to an outbreak of botulism across 10 states. ByHeart recalled “two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism,” the FDA announced.

The recall includes two lots of powdered formula with Dec. 1 “use by” dates, the FDA said in a statement Saturday. The lot numbers are 206VABP/251261P2 and 206VABP/251131P2. Parents and caregivers who have the product are advised to record identifying information at the bottom of the packaging and dispose of it immediately. Retailers are working to remove “all potentially impacted product” from store shelves.

Infant botulism, caused by a bacteria-produced toxin, can lead to constipation, poor feeding, loss of head control, difficulty swallowing, paralysis, and death, according to the Centers for Disease Control and Prevention. The FDA warned that symptoms may take weeks to develop and urged parents to monitor children closely after exposure.

The FDA noted 13 hospitalized cases of infant botulism in 10 states, with 13 infants having consumed ByHeart formula at some point. However, no direct link between the product and the cases has been confirmed. The agency emphasized that botulism is extremely rare in dairy products or infant formula and typically originates from environmental sources like soil or dust.

Symptoms of infant botulism include poor feeding, constipation, weak cry, and loss of head control. Parents are advised to seek immediate medical care if these signs appear.