ByHeart recalls baby formula after 13 infants diagnosed with botulism in US—what is it? Causes, risks, symptoms & more

ByHeart Inc is recalling some powdered infant formula after 13 infants developed botulism. The CDC and FDA are investigating the cases, with no confirmed contamination found yet. Infant botulism can cause serious health issues, but treatments are available, and no deaths have been reported.

Written By Riya R Alex
Updated9 Nov 2025, 08:52 AM IST
ByHeart Inc recalls baby formula after Botulism cases were reported in 13 infants.
ByHeart Inc recalls baby formula after Botulism cases were reported in 13 infants.

Baby formula maker ByHeart Inc has decided to recall some of its powdered formula after 13 infants were diagnosed with botulism following the consumption of its product, news agency Bloomberg reported.

The Centers for Disease Control and the FDA are currently probing 13 reported cases of infant botulism and hospitalizations in 10 states. The affected babies had consumed ByHeart brand powdered infant formula.

What is infant botulism?

Infant botulism is a rare and fatal disease that can cause a slow form of paralysis in infants. This condition typically affects babies under 1 year old. For infants over one year, the symptoms might differ, according to Cleveland Clinic.

Infant botulism can cause breathing issues and muscle paralysis and will need weeks of hospitalization, according to the CDC. Botulism can be fatal, however there are treatments for the disease. So far, there are no reported deaths of this specific outbreak.

Some of the symptoms of include choking, constipation, drooping eyelids and weakness.

Also Read | Zuckerbergs put AI at heart of pledge to cure diseases

What causes infant botulism?

Infant botulism is caused after a baby eats contaminated food containing bacteria Clostridium botulinum. This bacteria enters the infant's digestive system and start making toxins, which enters the and eventually impacts the nervous system.

The leftover baby formula is being tested to trace the origin of suspected contamination, the report quoted FDA and CDC.

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.

Also Read | Farmers need insurance payouts for climate setbacks without proving losses

“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,” the report quoted the statement of Mia Funt, ByHeart’s co-founder and president.

According to ByHeart webiste, the baby formula is advertised as being the “closest-to-breast-milk patented protein blend and made with organic, grass-fed whole milk.”

Key Takeaways
  • Infant botulism is a rare but serious condition that can lead to paralysis and requires hospitalization.
  • No contamination has been confirmed in ByHeart products yet.
  • Ongoing investigations by the FDA and CDC aim to trace the source of contamination and protect infant health.

Stay updated with the latest Trending, India , World and US news.

Business NewsNewsUs NewsByHeart recalls baby formula after 13 infants diagnosed with botulism in US—what is it? Causes, risks, symptoms & more
More
OPEN IN APP