Published
July 14, 2026
If you fed your baby ByHeart Whole Nutrition formula, here is what federal health agencies concluded, what the recall covers, and where the lawsuits stand. First, the practical point: all lots were recalled — do not use any of it.
Allegations Only · No Settlement Yet
The outbreak and recall facts on this page are attributed to the CDC and FDA. The lawsuits' liability claims are unproven allegations. ByHeart's recall was voluntary, the company has not been found liable, there is no certified class, and there is nothing to claim at this time. This page is informational and is not legal or medical advice — for a sick infant, seek medical care immediately.
What Is This About?
ByHeart, Inc., the maker of ByHeart Whole Nutrition Infant Formula, faces consolidated product-liability litigation after federal health agencies tied its formula to a 2025 outbreak of infant botulism. The cases are gathered as In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, before Judge Arun Subramanian in the U.S. District Court for the Southern District of New York.Infant botulism is a serious illness caused by Clostridium botulinum bacteria. According to the CDC, this was the first infant-botulism outbreak ever linked to infant formula. The most important practical point comes first: ByHeart recalled all lots and batches of its Whole Nutrition Infant Formula, so any remaining product should not be used. ByHeart has not been found liable in the litigation, and the lawsuits' liability claims remain unproven allegations.
Status
MDL Consolidated — In Litigation
MDL 3178 · S.D.N.Y. · Judge Arun Subramanian · consolidated Apr. 2, 2026 · ~21 actions
Outbreak & Recall (CDC / FDA)
48 infant cases · 17 states · all lots recalled
All infants hospitalized · no deaths reported · recall Nov. 8, 2025, expanded to all lots Nov. 11, 2025
Can I Claim?
No — nothing to claim yet
No settlement, no fund, no claim form at this stage
The Outbreak and Recall
In late 2025, the CDC, FDA, and state health departments investigated a multistate cluster of infant botulism. On November 7, 2025, the FDA notified ByHeart of the investigation, and the next day California public-health officials preliminarily detected botulinum neurotoxin in an opened can of ByHeart powdered formula that had been fed to an infant with lab-confirmed botulism.In its final outbreak numbers, the CDC reported 48 cases of infant botulism — 28 confirmed and 20 probable — across 17 states. All 48 infants were hospitalized and treated with BabyBIG, the botulism immune globulin used for infant botulism. No deaths were reported. The CDC declared the outbreak over on February 26, 2026.
The recall came in two steps. ByHeart first recalled two batches of its Whole Nutrition Infant Formula on November 8, 2025, then expanded the recall on November 11, 2025 to all lots and batches nationwide — both 24-ounce cans and single-serve "Anywhere Pack" sticks — in what it described as an abundance of caution. Because the recall now covers everything, the practical guidance is simple: do not use any ByHeart Whole Nutrition Infant Formula.
What the Agencies Found — and What's Still Open
It is important to separate what the agencies concluded from what remains under investigation. The CDC and FDA concluded, based on epidemiologic and laboratory data, that ByHeart Whole Nutrition Infant Formula was the source of the outbreak: every case-infant had consumed ByHeart formula before falling ill, FDA testing found Clostridium botulinum in ByHeart powdered-formula samples, and whole-genome sequencing matched a formula isolate to a clinical isolate from an outbreak infant. That sequencing further pointed to a lot of an ingredient — organic whole milk powder — used in the formula.What was not resolved is the ultimate root cause. As of mid-2026, the FDA had not determined exactly how or where the contamination occurred, citing the complexities of Clostridium botulinum, and its root-cause investigation remained ongoing after the outbreak was declared over. So: the formula as the outbreak source is agency-confirmed; the precise manufacturing or ingredient failure behind it is still being investigated.
What the Lawsuits Allege
The litigation runs on two tracks. In the personal-injury track, families of affected infants allege that contaminated ByHeart Whole Nutrition Infant Formula caused their children's botulism, and bring failure-to-warn, manufacturing-defect, negligence, and breach-of-warranty claims. In a separate track, putative class actions allege economic injury — that purchasers overpaid for, or were sold, unsafe or worthless formula — under consumer-protection and warranty theories.As with any complaint, the liability claims are allegations. ByHeart's recall was voluntary; the company has not admitted wrongdoing and has not been found liable. The agencies' conclusion that the formula was the outbreak source is a public-health finding, and it does not by itself establish legal liability, which the litigation will decide.
The MDL and Whether There's a Settlement
The Judicial Panel on Multidistrict Litigation consolidated the cases into MDL No. 3178 on April 2, 2026, sending them to the Southern District of New York before Judge Subramanian. At consolidation the MDL comprised roughly 19 actions — a mix of personal-injury and economic class actions — and it has grown modestly since, to around 21 cases as of mid-2026.There is no settlement. There is no fund, no claim form, and no deadline. The MDL is in its earliest organizational phase — leadership appointments and case-management — not a payout. Anyone presenting a "ByHeart settlement claim form" today is premature at best. If the cases resolve through a settlement, or a class is certified, a formal claims process would be announced separately.
Who Is Affected and What to Do
• Discard the formula: All lots of ByHeart Whole Nutrition Infant Formula were recalled — do not use any remaining product.• Watch for symptoms: The CDC advises seeking medical care right away if an infant shows signs of botulism, such as constipation, a weak cry, poor feeding, drooping eyelids, or decreased movement ("floppiness"). Infant botulism is treatable, and early care matters.
• If your infant became ill: Keep the product, its packaging and lot code, and all medical records.
• There is no claim to file right now; watch for news of a settlement or certified class.
For other product and drug cases, see OCA's mass tort lawsuits hub, and OCA's related coverage of infant-formula (NEC) litigation.
Frequently Asked Questions
Is there a ByHeart settlement yet?
No. MDL 3178 was consolidated in the Southern District of New York in April 2026 and is at its earliest stage. There is no fund, no claim form, and no deadline. ByHeart has not been found liable.How many infants were affected?
The CDC's final count was 48 cases (28 confirmed, 20 probable) across 17 states; all were hospitalized and no deaths were reported.Do I need to file a claim?
No. Because this is litigation and not a settlement, there is nothing to claim and no deadline. Discard any recalled formula, seek medical care for a sick infant, and keep records. If a settlement is reached, a claims process would be announced separately.Sources
• U.S. Centers for Disease Control and Prevention — infant botulism outbreak linked to infant formula (case counts, states, no deaths): CDC Outbreak Page• U.S. Food and Drug Administration — outbreak investigation of infant botulism (lab findings, root-cause status): FDA Outbreak Investigation
• U.S. Food and Drug Administration — ByHeart recall of all batches of Whole Nutrition Infant Formula: FDA Recall Notice
• Justia Dockets — In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178: Justia Docket (related case)
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Status
MDL Consolidated — In Litigation (no settlement)
Case
In re ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation
MDL Number
MDL No. 3178
Court
U.S. District Court, S.D.N.Y. · Judge Arun Subramanian
Consolidated
April 2, 2026 · ~21 actions
Recall
FDA · ByHeart Whole Nutrition Infant Formula · all lots · November 2025
FDA Recall Notice
FDA Recall Notice
