DeLauro Questions ByHeart Formula Sale After 48 Botulism Cases

By Olivia Hart

Forty-eight confirmed and probable infant botulism cases were linked to powdered ByHeart infant formula, and every affected infant was hospitalized across 17 states. The illnesses involved babies 16 to 264 days old, with onset dates running from Dec. 24, 2023, through Nov. 29, 2025.

Rep. Rosa DeLauro (D-CT) is questioning the sale of ByHeart formula to MeridianMade, a new company founded and led by ByHeart co-founders Ron Belldegrun and Mia Funt. The deal places the co-founders of the company at the center of another formula venture while the origin of the contamination remains unresolved.

In a statement, DeLauro said: “ByHeart was at the center of one of the most serious infant formula safety issues in recent memory. [Forty-eight] babies across 17 states were sickened by ByHeart’s formula, and every one of them hospitalized.” The episode remains the factual center of her scrutiny.

What does the sale change for parents?

For parents, the sale changes ownership, not the unresolved safety record. It offers no explanation of how, when or exactly where their children’s formula became contaminated. ByHeart has discontinued its formula, but DeLauro argues that step cannot end the search for safety answers.

Before companies continue to expand, parents deserve a full accounting of what failed and what will prevent a recurrence, DeLauro said. The announcement she questioned sets no deadline for the Food and Drug Administration’s root-cause work and no new regulatory condition tied to the sale.

The unresolved contamination chain

The FDA traced the contamination to an ingredient in the supply chain. It has not identified the exact origin of the bacteria or a root cause, leaving families without a complete explanation of how the formula became unsafe.

For manufacturers, the practical control point is upstream. FDA’s ingredient-level trace leaves supplier oversight and root-cause work central; discontinuing a finished product cannot substitute for either. That gap separates a market action from a completed safety explanation, which is why DeLauro says the co-founders’ new venture heightens the need for answers.

All 48 infants received BabyBIG®, the FDA-approved treatment for botulism developed by the California Department of Health. Every case involved hospitalization; the available information does not state recovery outcomes.

Where did the illnesses occur?

DeLauro’s statement breaks the 48 cases down across 17 states. The distribution lists each state’s case count as follows:

• Arizona: 5; California: 12; Idaho: 2; Illinois: 2; Kentucky: 1.
• Massachusetts: 2; Michigan: 1; Minnesota: 3; North Carolina: 2; New Jersey: 1.
• Oregon: 3; Pennsylvania: 1; Rhode Island: 1; Texas: 8; Virginia: 1.
• Washington: 2; Wisconsin: 1.

California, Texas and Arizona accounted for 25 of the 48 cases, just over half. The remaining 23 cases occurred across the other 14 states.

Why consolidation matters

DeLauro said: “Our infant formula market is even more consolidated than it was at the time of the 2022 outbreak that left families going to Facebook Marketplace to feed their children.” She welcomed that Abbott and Mead Johnson, which she described as infant formula giants, were not acquiring Perrigo’s formula business.

But she said she fears further consolidation as the market loses Perrigo as a manufacturer. The MeridianMade transaction sits within that broader concern, even though neither the announcement nor her statement provides a transaction price, production-cost data or pricing forecast. Its defensible focus is manufacturer concentration and safety accountability, rather than a documented effect on formula prices.

DeLauro said she will keep pressing for a full accounting of what went wrong and what is being done to prevent recurrence. She also said food for babies should meet the highest safety standards.

The forward-looking test is whether MeridianMade and the FDA can close those gaps before further expansion. Until they identify the bacterial source and complete a root-cause account, the ownership change leaves families with the same unanswered supply-chain questions DeLauro raised.