ByHeart Infant Formula Botulism Lawsuit: Where MDL 3178 Stands
Forty-eight infants were hospitalized. None died. The recall covered every can ByHeart had on the market, and the federal lawsuits are now consolidated before one judge in New York — with no settlement and no claim form.
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Reviewed by Leonard Goldberg, Editor · Last updated
What Happened
In November 2025, ByHeart recalled its Whole Nutrition Infant Formula after infants who had consumed it developed infant botulism. The recall began with two lots on November 8, 2025 and expanded three days later to every lot and every use-by date nationwide, covering both cans and the “Anywhere Packs.” The contamination was traced to Clostridium botulinum in a milk-powder ingredient; genetic sequencing identified 17 different strains, which points to an ingredient-supply problem rather than a single contamination event at one machine. The lawsuits allege that ByHeart failed to ensure the safety of its ingredient supply and its manufacturing, and that families were left feeding a contaminated product to newborns.
Case Details
The federal cases are consolidated as MDL No. 3178, In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, in the U.S. District Court for the Southern District of New York before Judge Arun S. Subramanian. The JPML transferred and centralized the cases on April 2, 2026, starting with 19 actions — nine brought by families of infants who became ill and ten class actions over economic loss by purchasers. The JPML census dated August 3, 2026 lists 21 pending actions.
Current Status — Verified August 22, 2026
Who Is Affected
The CDC's final count, published when it declared the outbreak over on February 26, 2026: 48 infants — 28 confirmed and 20 probable cases — across 19 states. All 48 were hospitalized. No deaths were reported. Because cases were identified retrospectively, the epidemiological trail reaches back to December 2023, so an illness that predates the recall by a long stretch may still belong to this outbreak. The personal-injury track concerns families whose infant was diagnosed with botulism after consuming ByHeart formula; the economic-loss track concerns anyone who purchased recalled product. Medical records — specifically the stool test confirming botulism — are the decisive documentation.
What This Could Pay (Honest Answer)
Case Timeline
- 1
November 8, 2025: The first recall
ByHeart voluntarily recalls two lots of Whole Nutrition Infant Formula after infants who consumed it are diagnosed with botulism.
- 2
November 11, 2025: Every lot recalled
The recall expands nationwide to all lots and all use-by dates, covering cans and Anywhere Packs — an unusually broad recall that signalled the company could not isolate the problem to a single batch.
- 3
December 2025 – February 2026: The count grows
Retrospective case-finding pushes the outbreak's trail back to December 2023. Investigators sequence 17 distinct Clostridium botulinum strains, pointing to a contaminated ingredient rather than a single plant incident.
- 4
February 26, 2026: CDC declares the outbreak over
Final tally: 48 infants across 19 states, all hospitalized, no deaths.
- 5
April 2, 2026: Cases consolidated as MDL 3178
The JPML centralizes 19 federal actions before Judge Arun S. Subramanian in the Southern District of New York — nine injury cases and ten economic-loss class actions.
- 6
What's next
Leadership appointments, plaintiff fact sheets and a case-management schedule come first; a bellwether calendar would follow. As of August 3, 2026 the docket held 21 pending actions. We update this page at each milestone.
Recall Scams to Watch For
Parents of a recently hospitalized infant are a vulnerable, easily identified group. A few patterns worth knowing.
“File your ByHeart claim here”
There is no claims portal and no settlement. A refund for recalled product goes through the retailer or ByHeart directly, and any injury claim goes through an attorney — never through a form on a site you have not heard of.
Callers who already know your baby's name
Formula purchase histories, baby registries and loyalty data circulate widely. Someone quoting real details back to you is not thereby legitimate. Verify through your own pediatrician's office or a number you already had.
“Guaranteed compensation for recall victims”
Nobody can guarantee an outcome in litigation that is four months old and has produced no verdicts. Attorneys in this field work on contingency; upfront fees are not part of it.
ByHeart Botulism Lawsuit FAQs
Is there a ByHeart settlement?
No. As of August 22, 2026 there is no settlement, no administrator and no claim form. The federal cases were consolidated on April 2, 2026 as MDL 3178 and remain in the early pretrial stage, with 21 actions pending as of the August 3 census.
My baby was sick but never tested for botulism — do we have a case?
That is the hardest situation in this litigation. Infant botulism is confirmed by a stool test, and without it, proving that a particular illness belongs to this outbreak is difficult. It is still worth talking to an attorney and requesting the complete medical records — sometimes testing was done and simply not discussed with the family.
We bought the formula but our baby never got sick. Anything for us?
That is the economic-loss track: class claims for the cost of recalled product you purchased. Those are typically modest per household and resolved collectively. Keep receipts, packaging and lot numbers if you still have them.
How can an illness from 2023 be part of a 2025 recall?
Investigators looked backwards. Once the outbreak strain was identified, previously unexplained infant botulism cases were re-examined and matched, which pushed the epidemiological trail back to December 2023. That is standard outbreak work, not a contradiction.
Does it matter that no infants died?
For the families, enormously — and infant botulism generally has a good prognosis when treated early. For the litigation, it shapes the damages picture: cases turn on hospitalization, treatment and its aftermath rather than on wrongful death. It does not make the claims invalid.
Had ByHeart been cited by the FDA before?
Yes. The FDA issued a warning letter in 2023 concerning significant violations at a Pennsylvania facility, and inspection findings at company facilities have included sanitation problems and environmental swabs positive for a different pathogen. Regulatory history of this kind commonly features in product-liability litigation, though it is not the same as proving what caused this outbreak.
What should we gather?
The stool test result and botulism diagnosis, hospital and treatment records including any BabyBIG administration, proof of purchase with lot numbers if available, and a record of costs and lost income. The diagnosis documentation is the piece that cannot be reconstructed later.
Separate from this case: were you injured in the last 2 years?
Class-action payouts are fixed amounts through an administrator. A personal injury claim is a different case — and often worth far more. Free estimate, no obligation.