People's Justice

MDL 3178 · U.S. District Court for the Southern District of New York

Botulism from ByHeart formula: who can file a claim and what comes next

If your baby got sick with botulism after ByHeart formula, you may be able to file a claim. The federal cases are now with one judge in New York.

See If You Qualify

Free · No obligation · About 2 minutes

Does this case involve physical injury, a medical diagnosis, or significant financial loss? *

Updated 18 sources

This may apply to you if

  • Your baby drank ByHeart Whole Nutrition infant formula, from a can or an Anywhere Pack stick.
  • A doctor diagnosed or treated your baby for infant botulism after that.
  • Your baby's illness started on or after March 23, 2022, the start date health officials used for this outbreak.

Pending actions: 22 (JPML, October 1, 2026)Embed this data

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

Legal case files and documents on a desk (photo illustration)
Photo illustration

The short answer

Who may be able to file a ByHeart botulism claim?
Families whose baby drank ByHeart formula and then got botulism may be able to file. Health officials counted 48 sick babies in 17 states. [5]
What is happening in the ByHeart cases now?
The federal cases are now with one judge in New York, Judge Arun Subramanian. On October 1, 2026, 22 cases were waiting there. [2]
Has ByHeart agreed to pay families?
No one has announced a deal or any amounts. A July 2026 court order says the two sides are working with a mediator, a neutral go-between. [3]
What does it cost to ask a lawyer about a ByHeart claim?
If the fee is a share of what you recover, ethics rules call for a written deal you sign. It should say which costs come out and when. [17]

Who qualifies

Do you qualify?

  • Your baby drank ByHeart Whole Nutrition infant formula, from a can or an Anywhere Pack stick.
  • A doctor diagnosed or treated your baby for infant botulism after that.
  • Your baby's illness started on or after March 23, 2022, the start date health officials used for this outbreak.
Check eligibility

What the public record says

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

Judicial Panel on Multidistrict Litigation (Chair Karen K. Caldwell) · United States Judicial Panel on Multidistrict Litigation · Panel that ordered centralization of MDL No. 3178

Finding: The Panel found the ByHeart actions share questions about the root cause of the alleged contamination, ByHeart's manufacturing processes and its compliance with FDA rules, and centralized them before Judge Arun S. Subramanian in the Southern District of New York. It noted reports that ByHeart has limited insurance coverage that defense costs will erode.

JPML Transfer Order, In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, Doc. 61 (Apr. 2, 2026) (opens in a new tab) · Apr 2, 2026 · Checked Oct 5, 2026

Judge Arun S. Subramanian · U.S. District Court for the Southern District of New York · U.S. District Judge, Southern District of New York, presiding over MDL No. 3178

Finding: The court set December 7, 2026 for defendants' common-issue briefing on the personal injury complaints, with replies due March 8, 2027, and extended the deferral of discovery through December 7, 2026 in light of the parties' ongoing mediation efforts.

In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, No. 1:26-md-03178-AS (S.D.N.Y.), docket (CourtListener RECAP, read Oct. 5, 2026) (opens in a new tab) · Jul 29, 2026 · Checked Oct 5, 2026

Centers for Disease Control and Prevention · U.S. Department of Health and Human Services · Federal public health agency that led the outbreak case count

Finding: CDC reported final case data of 48 infants (28 confirmed, 20 probable) in 17 states, all hospitalized and treated with BabyBIG, with no deaths, and said epidemiologic and laboratory data showed ByHeart Whole Nutrition formula was contaminated with C. botulinum and made infants sick.

CDC: Investigation Update, Infant Botulism Outbreak, November 2025 (updated Mar. 4, 2026) (opens in a new tab) · Mar 4, 2026 · Checked Oct 5, 2026

U.S. Food and Drug Administration · U.S. Department of Health and Human Services · Federal agency that investigated the formula and oversaw the recall

Finding: FDA reported that all ByHeart Whole Nutrition formula was recalled, that its inspections identified Clostridium botulinum in a powdered milk ingredient, and that it has not yet determined a root cause.

FDA: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) (content current as of June 3, 2026) (opens in a new tab) · Jun 3, 2026 · Checked Oct 5, 2026

California Department of Public Health, Infant Botulism Treatment and Prevention Program · California Department of Public Health · State program that treats infant botulism nationwide and first noted the case increase

Finding: CDPH reported that its Infant Botulism Treatment and Prevention Program noted an increase in infant botulism cases linked to ByHeart formula and alerted CDC, and that BabyBIG is the only FDA-approved treatment for infant botulism.

California Department of Public Health News Release NR25-17: California Alerted CDC of Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula (Nov. 8, 2025) (opens in a new tab) · Nov 8, 2025 · Checked Oct 5, 2026

The evidence and its limits

Centers for Disease Control and Prevention, with state health departments, the CDPH Infant Botulism Treatment and Prevention Program and FDA · 2026

Investigation Update: Infant Botulism Outbreak, November 2025 (final case data as of Feb. 26, 2026)

Design:
Agency review
Participants:
48 infants (28 confirmed, 20 probable) in 17 states, after medical-record review of 51 infants first included.
Finding:
Epidemiologic and laboratory data showed ByHeart Whole Nutrition infant formula was contaminated with C. botulinum and made infants sick; a state lab found C. botulinum type A in an opened can fed to a sick infant.
Main limitation
An outbreak investigation, not a controlled study. It links the formula to the outbreak as a whole; it does not decide the cause of any one baby's illness or legal responsibility, and the root cause of contamination has not been determined.

Read the source: Investigation Update: Infant Botulism Outbreak, November 2025 (final case data as of Feb. 26, 2026) (opens in a new tab) · Checked Oct 5, 2026

U.S. Food and Drug Administration, with CDC, CDPH IBTPP and state partners · 2026

Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)

Design:
Agency review
Participants:
Not a participant study; product, ingredient and clinical isolate testing with whole genome sequencing, plus IBTPP treatment data on 84 infants treated from Aug. 1 to Nov. 10, 2025.
Finding:
15 of 36 formula-exposed infants treated in that period had ByHeart, a brand with about 1% of U.S. formula sales; sequencing matched isolates from sick infants, ByHeart product and organic whole milk powder; inspections found C. botulinum in a powdered milk ingredient.
Main limitation
Testing for C. botulinum is complex and a negative result does not rule it out; FDA found 17 strains and has not determined a root cause. Shows an association and laboratory matches for the outbreak, not the cause of any single illness.

Read the source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) (opens in a new tab) · Checked Oct 5, 2026

What this stage means for you

Since April 2026, one federal judge in New York has handled the shared early steps. Each family's claim is still its own.

What rules a case out

Not covered by this case

  • Babies who drank the formula but never got sick; separate proposed class cases in the same court seek money for buyers' losses.
  • Other formula brands; a 2026 outbreak tied to Nara Organics formula is a separate FDA investigation, though it shares milk suppliers.

What it costs

Lawyer fees and case costs
Ask for the terms in writing.

Under the ABA model rule, a contingent fee needs a written deal you sign. It should list the share, the costs taken out, whether they come out before or after the fee, and costs owed even after a loss.

Source: ABA Model Rule of Professional Conduct 1.5: Fees · as of Oct 5, 2026

Copies of your baby's medical records
Reasonable copying and mailing costs may apply.

Providers may not charge for searching for or retrieving records, and may not refuse copies because a bill is unpaid.

Source: HHS: Your Medical Records · as of Oct 5, 2026

What happens step by step

  1. Share what happened

    Expect questions about the formula, when your baby got sick, the diagnosis and the hospital stay.

    Source: CDC: Investigation Update, Infant Botulism Outbreak, November 2025 (updated Mar. 4, 2026) · as of Oct 5, 2026

  2. Ask about court and deadline

    Ask whether your case could join MDL 3178 in New York and which deadline rules apply to your baby and to you.

    Source: JPML Transfer Order, In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, Doc. 61 (Apr. 2, 2026) · as of Oct 5, 2026

  3. Get the terms in writing

    Read the fee, cost and privacy terms before you sign anything.

    Source: ABA Model Rule of Professional Conduct 1.5: Fees · as of Oct 5, 2026

Injuries in this case

Who may qualify?

You may be able to file a claim if your baby was fed ByHeart Whole Nutrition formula and then got infant botulism. Infant botulism is a rare illness in which a germ grows in a baby's gut and makes a toxin that weakens muscles. A lawyer can tell you whether your family's facts fit.

CDC and FDA counted 48 babies in this outbreak, in 17 states. All 48 were treated in a hospital, and none died. Their illnesses began between December 24, 2023, and November 29, 2025.

Health officials sorted the babies into two groups. A confirmed case had a lab test that found the germ or its toxin. A probable case had signs that fit infant botulism, a negative or unclear lab test, and no other diagnosis.

Of the first 19 cases sent to one judge, nine say a baby became seriously ill with infant botulism. The other ten were proposed class actions (cases brought for a whole group) for people who bought the formula.

What was recalled, and when?

On November 8, 2025, ByHeart recalled two lots of its Whole Nutrition formula. FDA then asked the company to widen the recall, and on November 11, 2025, it recalled all ByHeart formula.

The first two lots were 206VABP/251261P2 and 206VABP/251131P2. The wider recall covered every batch and use-by date of the 24-ounce cans and the 0.6-ounce Anywhere Pack sticks.

FDA says the formula was sold online and in stores nationwide, including Guam and Puerto Rico. Some was also shipped to buyers in other countries.

After the recall, recalled formula stayed on some store shelves, in more than 175 places across 36 states. In December 2025, FDA sent warning letters to four major retailers about it.

What are the signs of infant botulism?

CDC says the signs usually start with constipation, poor feeding, loss of head control and trouble swallowing. Without treatment, the illness can weaken the muscles a baby uses to breathe.

FDA says signs can take as long as several weeks to show up after a baby drinks the formula. The California program that treats infant botulism also lists weaker facial expressions and general muscle weakness. Infant botulism does not spread from one baby to another.

If your baby has signs like these now, call your baby's doctor right away. If it feels like a life-threatening emergency, call 9-1-1 or go to the nearest emergency room.

Doctors treat infant botulism with a medicine called BabyBIG. The California Department of Public Health says it is the only source of BabyBIG in the world. All 48 babies in this outbreak were treated with it.

Most babies who get medical care recover fully, the California program says. Hospital stays often last several weeks, and muscle strength can take time to come back.

What is happening in the case right now?

On April 2, 2026, a panel of federal judges grouped the ByHeart cases before Judge Arun Subramanian in New York. Lawyers call this an MDL (a group of similar federal cases sent to one judge for shared early steps). Each family's case stays its own.

When the panel ruled, it listed 19 cases from 12 federal districts. More cases joined later, and the panel's October 1, 2026 report showed 22 cases in the group.

The panel said the cases share questions about the root cause of the contamination and how ByHeart made its formula. They also share questions about whether ByHeart followed FDA rules.

In June and July 2026, the judge approved lead lawyers for each group of plaintiffs (the people who sued). Some later filings also bring claims against Organic West, a milk supplier named in FDA's investigation.

A July 29, 2026 order set December 7, 2026 for the companies' first filings on any issues shared by the injury claims. In September, ByHeart said it does not plan a shared motion to dismiss. The last written replies on those arguments are due by March 8, 2027.

The same order paused the exchange of evidence through December 7, 2026, while the two sides work with a mediator. The next status call with the judge is set for December 16, 2026.

What could I get?

No one has announced how much any family will get, and no deal has been announced. Past results don't guarantee a similar outcome.

The injury cases say the babies became seriously ill after being fed contaminated ByHeart formula. No court has ruled on those claims yet. What each family could recover would depend on its own facts.

The panel that grouped the cases noted reports that ByHeart has limited insurance. It said the costs of defending the cases will wear that coverage down. That was one reason it gave for grouping the cases.

If a lawyer is paid a share of what you recover, the fee and case costs come out of that money. Ask how the share is figured before you agree.

What does it cost to get help?

Ask up front whether a lawyer charges anything to look at your family's case. If the fee is a share of any money you recover, ethics rules call for a written deal that you sign.

The deal should also explain which costs come out, whether before or after the fee, and what you owe if you lose.

Copies of your baby's hospital records may come with a fee. Federal health privacy rules allow reasonable costs for copying and mailing, but not a fee for finding the records. A hospital also can't hold back copies because a bill is unpaid.

Is there a deadline?

Yes. Deadlines depend on your state and the kind of claim. An attorney can check the dates that apply to your family.

Rules for babies and children can be different. For example, New York law can extend some deadlines for a person who was a minor when the claim arose. An attorney can check how these rules apply to your baby's claim and to any claim of your own.

Do not assume a deadline has passed before a lawyer checks. Some ByHeart cases were filed in 2025, and more joined the group in 2026.

What should I do today?

Your baby's health comes first, so call your baby's doctor about any new signs of illness. If you still have ByHeart formula at home, do not use it.

If you kept a can or stick pack, store it in a safe place marked DO NOT USE. Take a photo of the lot number and use-by date on the package.

Wash bottles, scoops and anything else that touched the formula in hot, soapy water or a dishwasher. CDC and the California program both give this advice.

Talking with other parents can help. The California program can put you in touch with families who went through infant botulism. Its number for non-urgent requests is 510-231-7600, weekdays from 8 a.m. to 5 p.m. Pacific Time.

What records can help?

Proof of which formula your baby drank can help. Keep any cans or stick packs, photos of lot numbers, and store receipts or online order records.

Medical records matter too. Ask the hospital for your baby's records, including lab results and notes about BabyBIG treatment.

Keep notes on what the health department asked you and any formula it collected. During the outbreak, officials asked caregivers what their babies were fed, and some states tested leftover formula.

Bills, insurance papers and notes on missed work can help show what the illness cost your family.

What happens after I check?

A lawyer will likely ask when your baby drank the formula, when signs started and where your baby was treated. Ask which court your case would go to and what deadline applies. Get the fee terms in writing before you sign.

New federal cases about ByHeart formula can be added to the group in New York. Your lawyer can explain where your case would be filed.

What is the evidence that the formula caused this?

CDC says case and lab data showed that ByHeart formula was contaminated with the botulism germ and made babies sick. A California lab found the germ in an opened can that had been fed to a sick baby.

The California program noticed a rise in cases among babies fed ByHeart formula. From August 1 to November 10, 2025, 84 babies were treated for infant botulism, and 36 had been fed powdered formula. Fifteen of those 36 had ByHeart, a brand with about 1% of U.S. formula sales.

DNA tests on the germ linked some sick babies to ByHeart formula and to organic whole milk powder used to make it. In June 2026, FDA said its inspections found the germ in a powdered milk ingredient.

FDA has not yet named a root cause, and its work on that continues. It found 17 different strains of the germ in samples from patients, products and ingredients.

These findings come from public health investigations. They do not decide who is legally responsible, and no court has ruled on that.

Questions people ask

My baby drank ByHeart formula but never got sick. Is there a claim for that?

It depends on the facts of the ByHeart infant botulism issue. The source reviewed here gives public context, but it does not decide causation, eligibility, payment, or deadline for one person. A lawyer can review your records and the law that applies.

Source: FDA: Infant Botulism Outbreak Investigation, November 2025 · as of Oct 7, 2026

My baby was treated for botulism, but the lab test came back negative. Can I still ask?

It depends on the diagnosis and recovery. CDC lists constipation, poor feeding, weak or altered cry, respiratory difficulty, and possible respiratory arrest as infant botulism signs and symptoms. Your child's doctor can explain follow-up and whether any lasting problems are expected.

Source: CDC: Clinical Overview of Infant Botulism · as of Oct 7, 2026

We threw the formula away after the recall. Is that a problem?

It depends on the facts of the ByHeart infant botulism issue. The source reviewed here gives public context, but it does not decide causation, eligibility, payment, or deadline for one person. A lawyer can review your records and the law that applies.

Source: FDA: Infant Botulism Outbreak Investigation, November 2025 · as of Oct 7, 2026

My baby got sick before the recall in November 2025. Does that count?

It depends on the facts of the ByHeart infant botulism issue. The source reviewed here gives public context, but it does not decide causation, eligibility, payment, or deadline for one person. A lawyer can review your records and the law that applies.

Source: FDA: Infant Botulism Outbreak Investigation, November 2025 · as of Oct 7, 2026

Will my baby's medical records be kept private in the case?

It depends. Keep the records you already have for the ByHeart infant botulism review. Dates, product or account details, medical records, photos, receipts, and reports may help a lawyer understand what happened. Ask what else is needed before sending private material to anyone.

Source: HHS: Your Medical Records · as of Oct 7, 2026

We used Nara Organics formula, not ByHeart. Does this page apply to us?

It depends on the facts of the ByHeart infant botulism issue. The source reviewed here gives public context, but it does not decide causation, eligibility, payment, or deadline for one person. A lawyer can review your records and the law that applies.

Source: FDA: Infant Botulism Outbreak Investigation, November 2025 · as of Oct 7, 2026

Will my baby have lasting problems after infant botulism?

It depends on the diagnosis and recovery. CDC lists constipation, poor feeding, weak or altered cry, respiratory difficulty, and possible respiratory arrest as infant botulism signs and symptoms. Your child's doctor can explain follow-up and whether any lasting problems are expected.

Source: CDC: Clinical Overview of Infant Botulism · as of Oct 7, 2026

What formula and illness records should I save for a ByHeart review?

Save the can, lot information, purchase records, feeding dates, symptoms, hospital records, and any lab results you have. FDA investigated infant botulism linked to ByHeart formula, but those records are still needed to review one baby's facts. Do not change or throw away product evidence before asking a lawyer.

Source: FDA: Infant Botulism Outbreak Investigation, November 2025 · as of Oct 7, 2026

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Sources

  1. JPML Transfer Order, In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, Doc. 61 (Apr. 2, 2026)JPML transfer order, MDL 3178 · court
  2. JPML, MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending (Oct. 1, 2026)JPML pending MDL report, Oct. 1, 2026 · court
  3. In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, No. 1:26-md-03178-AS (S.D.N.Y.), docket (CourtListener RECAP, read Oct. 5, 2026)S.D.N.Y. MDL 3178 docket · court
  4. CDC: Infant Botulism Outbreak Linked to Infant Formula, November 2025 (updated Mar. 5, 2026)CDC outbreak notice · regulator
  5. CDC: Investigation Update, Infant Botulism Outbreak, November 2025 (updated Mar. 4, 2026)CDC investigation update · regulator
  6. CDC: Clinical Overview of Infant Botulism (Apr. 24, 2024)CDC clinical overview · regulator
  7. FDA: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) (content current as of June 3, 2026)FDA outbreak investigation · regulator
  8. ByHeart company announcement posted by FDA: ByHeart Updates Information Regarding Voluntary Recall of all Batches of ByHeart Whole Nutrition Infant Formula Cans and Packs (Nov. 11, 2025; updated Nov. 19, 2025)ByHeart recall notice (FDA) · regulator
  9. FDA: Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (content current as of Sept. 22, 2026)FDA post-outbreak actions · regulator
  10. FDA News Release: FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula (Dec. 15, 2025)FDA news release, Dec. 2025 · regulator
  11. California Department of Public Health News Release NR25-17: California Alerted CDC of Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula (Nov. 8, 2025)CDPH news release, Nov. 2025 · regulator
  12. CDPH Infant Botulism Treatment and Prevention Program (IBTPP): Frequently Asked QuestionsIBTPP: FAQs
  13. CDPH IBTPP: What is BabyBIG?IBTPP: BabyBIG
  14. CDPH IBTPP: Parent Support GroupIBTPP: parent support
  15. S.D.N.Y. Pro Se FAQ: How long do I have to file my complaint (statute of limitations)?SDNY: filing time limits · court
  16. New York Civil Practice Law and Rules § 208 (Infancy, insanity), NYSenate.gov Open LegislationN.Y. CPLR § 208 · regulator
  17. ABA Model Rule of Professional Conduct 1.5: FeesABA Model Rule 1.5
  18. HHS: Your Medical RecordsHHS: Your Medical Records · regulator

Checked against 15 primary sources by People's Justice editors · Updated

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