Table of contents
- Latest ByHeart Formula Lawsuit Updates
- June 11, 2026: ByHeart Publishes Food Safety Action Plan
- June 3, 2026: FDA Reports Findings from ByHeart Plant Inspections
- April 2, 2026: Federal Panel Centralizes ByHeart Suits in New York
- March 26, 2026: Panel Hears Motion to Centralize ByHeart Cases
- February 26, 2026: CDC Declares ByHeart Botulism Outbreak Over
- December 10, 2025: Outbreak Expands to 51 Infants in 19 States
- November 22, 2025: Families Sue ByHeart over Infant Botulism
- November 12, 2025: Parents in Arizona and Kentucky Sue ByHeart
- November 11, 2025: ByHeart Recalls All Infant Formula Products
- December 11, 2022: ByHeart Recalls Five Batches over Cronobacter Risk
- What Is Infant Botulism?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- Is the ByHeart Formula Still Recalled?
- What Signs of Illness Should Parents Watch for After ByHeart Formula?
- What Should I Do If My Baby Drank ByHeart Formula?
- Where Do I Send a ByHeart Refund Request?
ByHeart Whole Nutrition Infant Formula was tied to an infant botulism outbreak, and families have sued the maker, ByHeart, Inc. ByHeart recalled every infant formula product it sold on November 11, 2025.
Plaintiffs allege the formula was contaminated and defective and that the company was negligent. The federal cases are now centralized in MDL No. 3178 in federal court in New York.
CDC and FDA counted 48 infants who became ill in 17 states. All were hospitalized, and no deaths were reported. CDC has declared the outbreak over, and ByHeart says production of all its products is paused.
Latest ByHeart Formula Lawsuit Updates
June 11, 2026: ByHeart Publishes Food Safety Action Plan
ByHeart published its food safety action plan, Food Safety Magazine reported [1]. The plan sets a new testing and verification protocol for C. botulinum.
It also adds more supplier audits and ingredient testing. The plan adds QR-enabled batch traceability and an independent Food Safety Advisory Council.
June 3, 2026: FDA Reports Findings from ByHeart Plant Inspections
FDA said it finished on-site inspections of ByHeart facilities [2]. The inspections led to the identification of Clostridium botulinum in a powdered milk ingredient.
They found no other factor inside the facilities that could explain the outbreak. FDA says the root cause investigation goes on, with a focus on ingredients.
April 2, 2026: Federal Panel Centralizes ByHeart Suits in New York
The Judicial Panel on Multidistrict Litigation moved nineteen actions from twelve districts into one case, MDL No. 3178, Law360 reported [3]. The case sits in the Southern District of New York before Judge Arun S. Subramanian.
ByHeart, Inc. is named in all nineteen actions. The actions come from families of ill infants and from people who bought the formula.
March 26, 2026: Panel Hears Motion to Centralize ByHeart Cases
The JPML heard the motion by plaintiffs Madison and Tyler Wescott to move the ByHeart actions to a federal court in New York. The hearing was held at its session in Birmingham, Alabama.
February 26, 2026: CDC Declares ByHeart Botulism Outbreak Over
CDC declared the outbreak over. Food Safety Magazine reported that FDA ended its outbreak investigation while the root cause work went on.
The last illness in the outbreak began on November 29, 2025. The final case data run through February 26, 2026.
December 10, 2025: Outbreak Expands to 51 Infants in 19 States
Federal health officials expanded the outbreak to 51 infants in 19 states, NPR reported [4]. The count covered all illnesses reported since ByHeart began production in March 2022. Officials said the infants were hospitalized and treated with BabyBIG.
November 22, 2025: Families Sue ByHeart over Infant Botulism
NBC News reported that at least four families had sued ByHeart [5]. They said their babies contracted botulism from contaminated formula. A separate class action was filed the week before. No court has ruled on these allegations.
November 12, 2025: Parents in Arizona and Kentucky Sue ByHeart
Parents in Arizona and Kentucky filed the first reported lawsuits against ByHeart in federal court, according to CBS News and the Associated Press [6].
They allege the formula was defective and the company was negligent. ByHeart said it would address any legal claims in due course.
November 11, 2025: ByHeart Recalls All Infant Formula Products
ByHeart recalled all of its infant formula products sold in the United States, according to the CDC recall notice [7]. NPR reported the same date.
The notice covers all lot numbers. It also covers all sizes of cans and single-serve packets, including the Anywhere Pack sticks.
December 11, 2022: ByHeart Recalls Five Batches over Cronobacter Risk
ByHeart voluntarily recalled five batches of ByHeart Whole Nutrition Infant Formula for possible Cronobacter sakazakii cross-contamination, according to the FDA 2022 recall notice [8].
FDA said no distributed ByHeart product had tested positive for the bacteria. The botulism lawsuits concern the November 2025 recall, not this earlier one.
What Is Infant Botulism?
According to the CDC investigation page, infant botulism happens when a baby swallows Clostridium botulinum spores. The spores grow in the gut and make toxin [9].
The ByHeart lawsuits involve infants who got this illness after being fed recalled ByHeart formula. They also involve people who bought that formula.
Who May Be Affected?
Infants who were fed ByHeart Whole Nutrition Infant Formula may be affected. Symptoms can take up to 30 days to appear. The formula was sold online and in store at major retailers nationwide.
People who bought the formula are plaintiffs in the economic injury class actions, which assert no illness. Whether a claim fits your family’s facts depends on an individual legal review.
Reported Injuries or Damages
CDC and FDA count 48 illnesses in 17 states. Of these, 28 are confirmed and 20 are probable. Every infant was hospitalized. FDA reports zero deaths.
The CDC investigation first counted 51 infants. It later dropped 3 who had other illnesses. CDC says epidemiologic and lab data showed the formula was contaminated with C. botulinum and made infants sick.
Plaintiffs allege serious illness, hospitalization, medical expenses, pain and suffering, and emotional distress. Class plaintiffs allege economic loss from buying the formula. The court has made no finding on liability.
FDA says whole genome sequencing matched two isolates from one lot of organic whole milk powder to ByHeart finished product samples. A clinical isolate matched too.
FDA collected the isolates at Dairy Farmers of America. That company processes milk powder for ByHeart supplier Organic West Milk, FDA says.
Recall and Regulatory Background
ByHeart first recalled two lots on November 8, 2025. They were lots 206VABP/251261P2 and 206VABP/251131P2. A recall of all products followed.
The CDC says to throw away any ByHeart formula you have and not use it. The ByHeart recall page explains how to get a refund [10]. Report illness through the FDA Safety Reporting Portal.
Evidence to Preserve
Keep these records and items. They may help show what your baby was fed and what happened next:
- Lot or batch numbers, and photos of the cans or Anywhere Pack sticks.
- Any formula left over, labeled and stored as CDC advises, and photographed before you throw it away.
- Receipts, order emails and refund emails.
- Your baby’s medical records, including BabyBIG treatment records.
- Hospital bills and other costs you paid.
- Notes on symptoms and the dates they began.
- Messages with ByHeart, stores and health departments.
Filing Deadlines
State law sets the deadline to file an injury claim, and the deadline for your family depends on where you live. It also depends on when the illness began and when the diagnosis happened.
If a family waits too long, the court may refuse the case no matter how strong the facts are. A lawyer can tell you which deadline applies, so ask early.
Potential Compensation
No settlement or verdict has been reported in the ByHeart litigation. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation depends on the facts of each claim.
Frequently Asked Questions
Is the ByHeart Formula Still Recalled?
Yes, the ByHeart formula is still recalled. ByHeart says production of all its products is paused. CDC says to throw away any formula you have, and FDA says it should not be for sale in stores or online.
What Signs of Illness Should Parents Watch for After ByHeart Formula?
After ByHeart formula, parents should watch for constipation, poor feeding and loss of head control. Other signs are trouble swallowing, drooping eyelids, a weak or altered cry and a flat facial expression. These can progress to trouble breathing.
What Should I Do If My Baby Drank ByHeart Formula?
If your baby drank ByHeart formula and shows any symptoms, seek immediate medical attention. Physicians treating the baby can call the CDPH clinical support line at 510-231-7600 for help.
Where Do I Send a ByHeart Refund Request?
Send a ByHeart refund request by email to hello@byheart.com, the address ByHeart gives on its recall page. ByHeart says all customers are eligible for a full refund for purchases placed on or after August 1, 2025.