Active Investigation · Recall in Effect

Infant Botulism Outbreak 2026

United States · Recalled infant formula · CDC & FDA investigation
Sources: CDC Infant Botulism Outbreak.

About Infant Botulism

Cause
Clostridium botulinum spores that grow in a baby's gut and make a nerve toxin
Who it affects
Babies under 1 year, whose gut cannot yet keep the spores in check
Spreads by
Swallowing spores in food or dust, not person to person
Treatment
BabyBIG antitoxin plus hospital supportive care

What is infant botulism?
Infant botulism is a rare but serious illness that happens when a baby swallows spores of the bacterium Clostridium botulinum. In a baby's immature gut the spores can grow and release a toxin that blocks the nerves controlling muscle movement. Older children and adults almost never get sick this way because a mature gut keeps the bacteria from taking hold.

How is it treated?
The specific treatment is an antitoxin called BabyBIG, given in hospital, alongside supportive care while the toxin wears off. Started promptly it shortens the illness, and with good care most babies recover fully. Seek care immediately if a baby shows poor feeding, a weak cry, drooping eyelids, or a floppy loss of head control.

How do you prevent it?
There is no vaccine. Prevention means not feeding babies any recalled product, and never giving honey to a child under one year, since honey is a known source of botulism spores. Breast milk and properly prepared formula that has not been recalled remain safe.

Sources: CDC About Botulism · Infant Botulism Treatment Program

Treatments & Vaccines in Development

Infant botulism is treatable, and with prompt care the outlook is good. There is no vaccine, so prevention comes down to avoiding recalled products. Here is what treats it and where prevention stands.

BabyBIG (Botulism Immune Globulin)Antitoxin
Approved and in use
Infant Botulism Treatment and Prevention Program (California Dept. of Public Health)

BabyBIG is the FDA-approved treatment for infant botulism. It is an antitoxin made from human antibodies that neutralizes the botulinum toxin, and given early it shortens hospital stays and speeds recovery. All four infants in this outbreak were treated with it. It is supplied through a single national program rather than ordinary pharmacies, so hospitals request it directly when infant botulism is suspected.

Infant Botulism Treatment and Prevention Program
Supportive hospital careSupportive care
Standard of care
Standard of care

Because botulism weakens the muscles used to feed and breathe, babies are hospitalized and supported while the toxin wears off, which can include feeding assistance and, in severe cases, help with breathing. With prompt antitoxin and good supportive care, most infants recover fully. No deaths have been reported in this outbreak.

CDC Botulism
Botulism vaccineVaccine
None for the public

There is no botulism vaccine for the general public or for infants. Prevention instead relies on food safety, avoiding recalled products, and keeping honey away from babies under one year. An investigational toxoid vaccine exists only for laboratory and military use, not for routine protection.

CDC Botulism Prevention
Approved / in usePositive trial resultsIn clinical trialsEarly researchHalted