Injury guide

Infant botulism

Updated Oct 6, 202618 sources

Infant botulism is a rare illness in which germs grow in a baby’s gut and make a poison. Here is how it is found and what the ByHeart formula lawsuits claim.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

Centers for Disease Control and Prevention · U.S. Department of Health and Human Services · Publisher of the ByHeart infant botulism outbreak investigation update

“Epidemiologic and laboratory data showed that ByHeart Whole Nutrition infant formula was contaminated with C. botulinum and made infants sick.”

CDC: Investigation update, infant botulism outbreak (opens in a new tab) · Mar 4, 2026 · Checked Oct 5, 2026

Judicial Panel on Multidistrict Litigation · U.S. federal courts · Panel that grouped the federal ByHeart cases (MDL No. 3178); summary of the claims, not a ruling

“Plaintiffs in nine actions allege that their infant children became seriously ill with infant botulism after being fed contaminated ByHeart formula.”

JPML transfer order, ByHeart MDL No. 3178 (April 2, 2026) (opens in a new tab) · Apr 2, 2026 · Checked Oct 5, 2026

The evidence and its limits

Centers for Disease Control and Prevention · 2026

Investigation update: infant botulism outbreak linked to infant formula, November 2025

Design:
Agency review
Participants:
48 infants in 17 states: 28 confirmed and 20 probable cases.
Finding:
CDC said epidemiologic and laboratory data showed that ByHeart Whole Nutrition formula was contaminated with C. botulinum and made infants sick. All 48 infants were hospitalized, and none died.
Main limitation
Twenty of the 48 cases were probable, without a positive lab test. The source of the contamination was still under FDA investigation, and the count does not say which families are in the lawsuits.

Read the source: Investigation update: infant botulism outbreak linked to infant formula, November 2025 (opens in a new tab) · Checked Oct 5, 2026

The short answer

What is infant botulism?
Infant botulism happens when a baby swallows germ spores. The spores grow in the gut and make a poison that weakens the muscles. It is a medical emergency. [1]
What are the signs of infant botulism, and when should I see a doctor?
Early signs are often constipation and poor feeding. A baby may have drooping eyelids, a weak cry and less expression in the face. If you see these signs, see your doctor or go to the emergency room right away. [2]
How do doctors diagnose infant botulism?
Doctors first make the diagnosis from the baby’s signs. A stool test done by a state public health lab can confirm it. In the ByHeart outbreak, CDC also counted some babies with negative or unclear tests as probable cases. [3]
Which records show an infant botulism diagnosis?
The hospital chart shows the baby’s signs and the doctor’s diagnosis. The state lab report shows whether the stool test found the poison or the germ. The state health department also gets a report on each case. [3]

What rules a case out

Not covered by this case

  • This page is not medical advice. Call your baby’s doctor about your baby’s care.
  • It does not cover how infant botulism is treated. Our ByHeart treatment page explains that.
  • It also does not cover botulism in older children and adults.

What is infant botulism?

Infant botulism happens when a baby swallows germ spores. The spores grow in the gut and make a poison that weakens the muscles. It is a medical emergency.

The germs are found in many places in nature. Some foods, like honey, can carry them. It is rare for them to make people sick.

It mostly affects babies between 6 weeks and 6 months old. It can happen as early as 6 days or as late as 1 year.

CDC says it does not know why some babies get sick from the spores, and that most cases cannot be prevented. It does say not to give honey to a child under 1 year old.

CDC says the germs can be found in soil and dust, and even inside homes after cleaning. California’s state infant botulism program says that in most cases no source is found. It says most sick babies likely swallowed spores stuck to tiny bits of dust in the air.

What are the signs of infant botulism, and when should I see a doctor?

Early signs are often constipation and poor feeding. A baby may have drooping eyelids, a weak cry and less expression in the face. If you see these signs, see your doctor or go to the emergency room right away.

Pupils that are slow to react to light can be another sign. CDC says not to wait. MedlinePlus says to go to the emergency room or call 911 right away if your baby has symptoms.

CDC says signs usually show up within 30 days after a baby swallows the spores.

How do doctors diagnose infant botulism?

Doctors first make the diagnosis from the baby’s signs. A stool test done by a state public health lab can confirm it. In the ByHeart outbreak, CDC also counted some babies with negative or unclear tests as probable cases.

On exam, a doctor may find weak, floppy muscles, a weak gag reflex and drooping eyelids.

For counting cases, public health calls a case confirmed when a baby under 1 has signs that fit and a lab finds the poison or the germ.

Our ByHeart treatment page explains more about testing and care in the hospital.

Which records show an infant botulism diagnosis?

The hospital chart shows the baby’s signs and the doctor’s diagnosis. The state lab report shows whether the stool test found the poison or the germ. The state health department also gets a report on each case.

CDC says almost all known cases in the U.S. are recorded, and cases confirmed by a lab are reported to CDC.

In the ByHeart outbreak, health officials reviewed the babies’ medical records. A case counted as confirmed if the baby had the formula and a positive lab test. It counted as probable if the baby had the formula, the test was negative or unclear, the illness fit and no other cause was found.

Parents can ask the hospital for copies of the chart and test results. HHS says the hospital normally has up to 30 days to give you a copy. It cannot refuse because a bill is unpaid.

What does research say about ByHeart formula and infant botulism?

CDC said lab tests and case data showed that ByHeart formula had the germ and made babies sick. There were 48 cases in 17 states. Lab tests confirmed 28, and 20 were probable. None of the babies died.

In March 2026, CDC said: “Epidemiologic and laboratory data showed that ByHeart Whole Nutrition infant formula was contaminated with C. botulinum and made infants sick.” CDC has said the outbreak is over.

FDA found the germ in a powdered milk ingredient. As of August 2026, FDA was still looking for the root cause.

In August 2026, FDA looked at a second, smaller outbreak: 4 babies who drank Nara Organics formula. It said DNA test results and shared milk suppliers point to a common source of contamination for both outbreaks. FDA has not yet found the root cause.

These agency findings are about the outbreak as a whole. We found no court ruling that ByHeart formula caused any one baby’s illness.

Who brings infant botulism claims in the ByHeart cases?

Families say their babies got very sick with infant botulism from ByHeart formula that had the germ in it. Other cases are about what people paid for the formula. Each family’s own facts decide whether it has a claim.

In April 2026, the federal cases were grouped before Judge Arun S. Subramanian in New York. The panel that grouped them said the cases share questions of fact.

As of early October 2026, the court’s orders dealt with schedules and other early steps. None had ruled on whether the formula caused the illnesses. The next court meeting is set for December 16, 2026.

CDC’s count of outbreak cases and the lawsuits are separate. We did not confirm whether any family in the lawsuits is one of CDC’s 48 cases.

Can a parent get a baby’s infant botulism records?

Usually, yes. HHS says a parent is normally the one who can use a minor child’s rights to health records. It names a few exceptions where a parent does not have that role.

When a baby has died, the person who runs the estate, called the executor or administrator, may get the records that job requires. Doctors may also share some facts with a family member who was involved in the baby’s health care or in paying for it. They can share only what relates to that role. State law sets who can act in each role.

If your baby has died, the wrongful death case page explains in general how those claims work.

Sources

  1. CDC: Investigation update, infant botulism outbreak
  2. CDC: Symptoms of botulism
  3. CDC: Clinical overview of infant botulism
  4. JPML transfer order, ByHeart MDL No. 3178 (April 2, 2026)
  5. CDC: About botulismCDC: About botulism · regulator
  6. CDC: Infant botulism case definition (2011)CDC: Infant botulism case definition (2011) · regulator
  7. MedlinePlus: Infant botulismMedlinePlus: Infant botulism · regulator
  8. CDC: Botulism preventionCDC: Botulism prevention · regulator
  9. California Department of Public Health, Infant Botulism Treatment and Prevention Program: Preventing infant botulismCalifornia Department of Public Health, Infant Botulism Treatment and Prevention Program: Preventing infant botulism
  10. CDC: National botulism surveillanceCDC: National botulism surveillance · regulator
  11. HHS: Your right to access your health informationHHS: Your right to access your health information · regulator
  12. HHS: Personal representatives under HIPAAHHS: Personal representatives under HIPAA · regulator
  13. CDC: Infant botulism outbreak linked to infant formula, November 2025CDC: Infant botulism outbreak linked to infant formula, November 2025 · regulator
  14. FDA: Outbreak investigation of infant botulism, infant formula (November 2025)FDA: Outbreak investigation of infant botulism, infant formula (November 2025) · regulator
  15. FDA: Outbreak investigation of infant botulism, powdered infant formula (2026)FDA: Outbreak investigation of infant botulism, powdered infant formula (2026) · regulator
  16. CourtListener docket, ByHeart MDL No. 3178 (S.D.N.Y.)CourtListener docket, ByHeart MDL No. 3178 (S.D.N.Y.) · court
  17. HHS: Health information of deceased individualsHHS: Health information of deceased individuals · regulator
  18. eCFR: 45 CFR 164.502(g), personal representativeseCFR: 45 CFR 164.502(g), personal representatives · regulator

Checked against 18 primary sources by People's Justice editors · Updated

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