According to NBC New York, 13 babies across 10 U.S. states have been hospitalized with infant botulism, a dangerous condition that affects the nervous system, after consuming ByHeart’s Whole Nutrition Infant Formula. Thankfully, no deaths have been reported.

What’s Going On?

The U.S. Centers for Disease Control and Prevention (CDC) says the outbreak began in mid-August and has affected babies as young as 2 weeks and as old as 5 months. The cases were reported in states like California, Texas, New Jersey, and Washington.

 

On November 8, ByHeart recalled two batches of its powdered formula after early tests suggested the presence of bacteria that can cause botulism. The company says more testing is underway and that it’s working closely with health officials.

 

What Is Infant Botulism?

Infant botulism is caused by a type of bacteria (Clostridium botulinum) that produces a toxin in the baby’s large intestine. It’s rare, but very serious. Early signs include constipation, weak feeding, a soft cry, and floppy limbs. If not treated, it can lead to paralysis and breathing problems.

 

All the affected babies received a special treatment called BabyBIG, a medicine made from blood plasma that helps fight the toxin. Some needed help breathing with machines.

 

Will There Be a Formula Shortage?

No. The FDA says ByHeart makes up only about 1% of U.S. formula sales, so this recall won’t cause a national shortage like the one in 2022.

 

What’s Next?

The FDA is investigating 83 cases of infant botulism reported since August and has launched a new review of formula ingredients under “Operation Stork Speed,” led by Health Secretary Robert F. Kennedy Jr.

 

ByHeart says it takes the issue seriously and is committed to safety. The recalled formula has a best-by date of December 2026.