ITHACA, NY (607NewsNow) – The FDA is recalling ByHeart infant formula products.

The recall, which was first reported over the weekend, was expanded to include all ByHeart products on November 10 due to an ongoing nationwide outbreak of infant botulism.

As of Monday, there has been 15 suspected or confirmed cases in 12 states, though none in New York. FDA officials say detecting of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

Additionally, symptoms can take weeks to develop after ingestion. Most infants will initially be constipated, have trouble feeding, a decrease in facial expressions, loss of head control, and will have difficulty swallowing. It can progress to difficulty breathing, respiratory arrest, and death.

ByHeart products were sold online and in-store at major national retailers.

Parents and caregivers are advised to stop using ByHeart products immediately. If your child consumed the product and is experiencing symptoms, seek medical attention immediately. If your child consumed the formula but is asymptomatic, monitor them and seek medical attention if symptoms develop.

If you still have the product in your home, you’re asked to take a photo or record the information on the bottom of the package. Keep the container in a safe spot and label DO NOT USE. Should your child develop symptoms, the NYS Department of Health may want to collect your formula for testing.

The investigation to find the source point of contamination is ongoing. No nationwide formula shortage is expected as a result of the recall.

Questions? Call ByHeart at (833) 429-4327.