A hat tip to Anna Edney at Bloomberg News, who has done as much as any reporter in the country to keep infant formula safety in front of the public, for breaking the news today that the people who ran ByHeart are about to become major players in the store-brand formula business.

According to Edney’s story, a company led by ByHeart co-founders Ron Belldegrun and Mia Funt – a brother and sister who are now CEO and president of MeridianMade, a contract manufacturer – has agreed to buy Perrigo’s infant formula business for up to $175 million. Dublin-based Perrigo makes the store-brand formula sold under retailer labels across the country. Perrigo says the sale, expected to close in the first half of 2027, will let it focus on its consumer self-care products.

Most important for the families: a MeridianMade spokesperson told Bloomberg that ByHeart has been “discontinued” and will not relaunch. ByHeart formula is not coming back.

So, ByHeart is gone for good. The babies it sickened, and their families, are not. Before everyone moves on, here is a reminder of what happened and why.

What Happened

In October 2025, California’s Infant Botulism Treatment and Prevention Program noticed that three infants with suspected infant botulism had all been fed the same powdered formula – ByHeart Whole Nutrition. The signal was hard to miss. ByHeart had roughly one percent of U.S. powdered formula sales, yet of the 36 infants treated with BabyBIG between August 1 and November 10, 2025, who had any powdered-formula exposure, 15 – more than 40 percent – had been fed ByHeart. The FDA’s own internal outbreak record called that “highly unusual.”

It was the FDA, not ByHeart, that asked for the recall: two lots on November 8, 2025, then every ByHeart product on November 11. ByHeart’s own testing soon found Clostridium botulinum in five of 36 unopened cans spanning three lots.

When the CDC declared the outbreak over on February 26, 2026, the final count was 48 infants – 28 confirmed and 20 probable – in 17 states. Every one of them was hospitalized and treated with BabyBIG. Thankfully, none died. But illness onsets ran from December 24, 2023, to November 29, 2025, and ByHeart reported that one positive lot had a production date of November 15, 2024 – meaning contaminated formula was being made and sold nearly a year before the recall. Preliminary CDC data found that about two-thirds of the infants evaluated needed physical therapy or feeding support after they left the hospital. According to the FDA, this was the first botulism outbreak tied to infant formula anywhere in the world since infant botulism was first described about fifty years ago.

Why It Happened

Edney accurately reports that federal inspectors found no evidence ByHeart’s production process caused the outbreak. That is where the story starts, not where it ends. C. botulinum was found in finished formula, in the base mix, and in the organic whole-milk powder ByHeart bought from Organic West Milk, which was spray dried by Dairy Farmers of America in Fallon, Nevada. The FDA sequenced 37 isolates and sorted them into 17 strains. One of those strains tied together a milk-powder retain at Dairy Farmers of America, ByHeart’s own whole-milk powder, its finished formula, an unopened can from an Arizona family, and a sick baby in New Jersey.

Powdered infant formula is not sterile, and heat that kills Salmonella and Cronobacter does not reliably kill botulism spores. Nor did the indicator tests the industry relies on see the hazard – ByHeart itself reported that every sample in which its lab presumptively detected C. botulinum had sulfite-reducing clostridia below the level those tests flag.

None of that lets a formula maker off the hook. The FDA has said for years, and repeated in its July 13, 2026, letter to the entire infant formula industry, that suppliers of ingredients that will not receive a lethal treatment at the formula plant are an extension of the manufacturing process. If you put it in the can and sell it to parents, you own it. And ByHeart’s compliance history was hardly spotless: an FDA Warning Letter at its former Reading, Pennsylvania plant in 2023, and Form 483 inspection findings at its Allerton, Iowa base-powder plant in February 2025 and again in January 2026.

Then there is Nara Organics. When ByHeart recalled its formula, it steered its customers to Nara with a 20 percent discount code in a since-deleted Instagram post. Nara’s formula was made with milk from the same Organic West Milk, spray dried by the same Dairy Farmers of America. During the ByHeart investigation, Organic West Milk gave the FDA a customer list that left out Nara’s manufacturer. In June 2026, Nara recalled all of its whole-milk formula; the CDC closed that outbreak on August 27 with four confirmed infant botulism cases in California, Pennsylvania and Washington, all hospitalized. Whole genome sequencing matched a Nara baby’s isolate to a ByHeart baby, to ByHeart’s base powder, and to four sealed, unopened ByHeart cans. The FDA concluded the matching sequences, and shared suppliers indicate a common source. It still has not said whether the milk was contaminated before or during drying, and its root-cause investigation remains open.

What Comes Next

The outbreaks forced a real response. The FDA’s July 2026 industry letter, a joint FAO/WHO expert meeting that added botulinum-producing clostridia to the priority hazard list for powdered formula, and a Reagan-Udall Foundation roundtable all reached the same conclusion – there is no standardized method to find C. botulinum in formula, and the industry cannot rely on indicator testing to catch it.

Which brings me back to today’s news. Perrigo makes the store-brand formula that a great many families on tight budgets depend on – and Perrigo’s own Wisconsin formula plant received an FDA Warning Letter on the same day in August 2023 that ByHeart did. That business is about to be run by the people who ran ByHeart. Before it was discontinued, ByHeart said it would not resume production without C. botulinum-specific testing of every dairy ingredient and every finished batch. ByHeart will never resume, so that promise was never tested. MeridianMade should make that same commitment, publicly, for every can that leaves the Perrigo plants.

Better yet, safety should not depend on any one company’s promise. That is why I am pushing for required C. botulinum testing of powdered infant formula and its dairy ingredients – both through H.R. 7867 and through the FDA citizen petition I am filing with ByHeart and Nara parents as Co-Petitioners. Public comments on the draft petition are due tomorrow, October 30.

Marler Clark represents families whose babies were hospitalized in both the ByHeart and Nara Organics outbreaks. Executives can sell, buy and rebrand. These families do not get to start over.