On Thursday, June 11, 2026, the FDA quietly posted on its website a document that those investigating the ByHeart infant botulism outbreak had been waiting months to confirm: the full Establishment Inspection Report (EIR) from Blendhouse Allerton, LLC, the Iowa plant that produced ByHeart infant formula base powder.
Source: Bloomberg’s Anna Edney was the first to report the release, reporting that federal inspectors found no evidence that ByHeart’s own production “caused” the outbreak, instead pointing to contaminated ingredients. You can read her work here. The FDA has found no evidence that ByHeart production has resulted in cases of infant formula botulism. She’s right. But the 55-page government report says much more than any headline, so I read it all.
Same goes for you. Here’s the actual original document: FDA Establishment Inspection Report, Blendhouse Allerton, LLC (FEI 1921383), Inspection 11/11/2025–01/22/2026 — https://www.fda.gov/media/192916/download.
This full EIR is different from the three-page Form FDA 483 issued last January and is a much longer document. 483 is Attachment 1 to this report. The explanation, findings and FDA conclusions are in the EIR, which was released Thursday.
Here’s what the FDA actually concluded:
After spending several weeks in the field, FDA investigators wrote on page 35 that genetic matches between Clostridium botulinum-positive ingredients and sick infants and previously manufactured finished products “appear to indicate that raw materials were more likely the source of the outbreak than the company’s processing equipment and storage practices.”
In plain English, it’s most likely that spores got on the ingredients.
The ingredient is organic whole milk powder. The report describes how ByHeart’s vice president of quality told the FDA on January 21, 2026, that a number of organic whole milk powders tested presumptively positive for C. botulinum and that one isolate matched both clinical samples from sick babies and ByHeart finished products (pp. 31-32). The CORE team identified organic whole milk powder as an “ingredient of concern” (page 34). FDA collected and sent 12 base powder samples associated with the recalled finished product lots (251131P2, 251261P2, 251481P2, and 243201P2) for botulinum testing (pp. 47-48).
Pouring milk: Organic West Milk → Dairy Farmers of America → Organic West Milk → ByHeart
EIR redacts supplier names, but the supply chain is no longer a secret. As first reported by Jonel Aleccia of the Associated Press, the organic whole milk powder is made from liquid organic whole milk sourced from Organic West Milk, Inc., a California company that pools milk from 55 farms, then dried and made into powder at the Dairy Farmers of America (DFA) plant in Fallon, Nevada. DFA dried milk for Organic West Milk, Inc., which sold the powder to ByHeart, and the lots the FDA collected from the DFA plant were genetically consistent with the outbreak strain.
So the chain runs like this:
- Liquid Whole Milk — Organic West Milk, Inc. (California, 55 farms)
- Powdered Milk — Dairy Farmers of America, Fallon, Nevada, USA (milk drying)
- Infant Formula Base Powder — ByHeart from Blendhouse Allerton, Iowa
- Finished Canning Formula — ByHeart’s Blendhouse Portland, Oregon Factory
- Retail store — the store that sold the cans to the parents.
FDA investigators collected “DFA’s Audit Observations” as Exhibit 81 (p. 51) along with ingredient tracking.
And as expected, the accusations began. ByHeart points upstream, with the DFA emphasizing that end product manufacturers are responsible for properly handling ingredients for safety, while Organic West’s owners suggested there was a problem with turning milk into powder and powder into formula. Everyone in the chain is pointing to the next link.
“The ingredients did it” does not mean:
I want to be very clear here because the spin will be large. Identifying the contaminated milk ingredients doesn’t save ByHeart from the problem. Neither legally nor morally.
Blendhouse Allerton is the sole producer of the base powder used in ByHeart formulas (page 1). And the same report pointing upstream also forwarded ByHeart a new three-item Form 483 (pages 41-44).
- Undocumented process intrusion flush after black rubber fragments found in line – 21 CFR 106.50(a)(1);
- It was discovered that the company had not ensured that all ingredient contact surfaces were cleaned and sanitized, particularly oil storage silos that had not been subjected to secondary caustic cleaning, which required their own procedures. 21 CFR 106.30(b) and
- Base mixtures that fall below the required temperature and are supplied without management approval—if the company fails to assess the public health significance of the deviation—21 CFR 106.6(c)(4).
What’s worse is that two observations from the February 2025 inspection were still reflected in this report as “not corrected.” namely, failure to maintain a building in a clean and sanitary condition (21 CFR 106.20(a)) and authorizing and releasing ingredients that were not stored under conditions to prevent adulteration (21 CFR 106.40(f)(3)) (pp. 2-3). Read the last one again. Months before the babies got sick, the FDA had already cited the plant for emitting substances that were not maintained under conditions intended to prevent adulteration, and the issue was still not resolved at the time the outbreak was reported. And take a look at what the February 2025 survey actually found: The first observation named the exact ingredient currently at the center of this outbreak. The FDA cited plants that receive and release whole organic milk powder that has not been stored under conditions that prevent adulteration (page 1). The same inspection faulted the company for failing to remove rodent habitats after a 2024-2025 rodent problem and failing to properly monitor dryer floors after Cronobacter sakazakii, a pathogen that can be fatal to infants and led to a large 2022 Abbott formula recall, was identified (pp. 1-2). The plant had already been notified of baby-killing organisms in milk, rodents and dryers months before one child became ill.
And the bottom line is that Clostridium botulinum spores in dairy products are a known and predictable risk. The entire mission of infant formula manufacturers is to control the risks of the ingredients they purchase. Because the end product reaches the most vulnerable humans on the planet. This is because the immature human intestines allow the spores to germinate and produce toxins. ByHeart’s own “action plan” dated June 10 now commits to C. botulinum-specific testing of all dairy ingredients and all finished batches prior to launch. This is an implicit acknowledgment that this risk is always testable and controllable. You cannot receive credit for installing smoke detectors after your home has burned down. The dangers of this plant were not hypothetical. In January 2025, BHA’s own records (SNC25-002-BHA) document rodent contamination with pallets of organic whole milk powder arriving with visible holes, spilled powder and potential rodent droppings (page 15), with the very ingredients carrying C. botulinum spores. The FDA ultimately concluded that specific contaminated pallets were not the cause of the outbreak. This was in relation to another lot received from another warehouse (page 35). But this misses the larger point. Plants, who have already watched chewed-up and soiled bags of formula come through the door, know exactly how dirt gets into this stuff and why all formula must be controlled before it reaches the baby.
conclusion:
48 infants were hospitalized in 17 states. No one died. But botulism can leave lasting damage, and these are babies. FDA reports do the real, important work of tracing spores back to baby formula ingredients and the companies that supplied and processed them. Organic West Milk and Dairy Farmers of America can and should answer for the lot carrying the outbreak strain. The scale of the risk is in the report itself. The recall began with two lots on November 8, 2025, and expanded to all ByHeart formulas by November 19, which the FDA classified as Class I. This is the agency’s most serious category, reserved for products that can cause serious injury or death. The matter was still ongoing when investigators closed this report (pp. 8-9).
But companies that label cans of infant formula and market them as the closest thing to breast milk can’t outsource responsibility for what’s inside. ByHeart selected suppliers, purchased ingredients, created base powders, and sold the products to parents who trusted them. Pointing to the milk explains how the spores got there. The person responsible for preventing spores does not change. Cost and baby bottles have been discontinued at ByHeart.
And the responsibility does not end with Buy Heart. Any company that sold this product to my family is part of a chain that distributes adulterated and dangerous products. Under long-established product liability laws, sellers in those chains could be held strictly liable for getting them into the hands of parents, even if they didn’t know what was in the cans. Grocery chains, pharmacies, big-box stores and online sellers that stocked and shipped the recalled ByHeart formula benefited by getting the product into the hands of the most vulnerable consumers. This entails legal and moral obligations. When a retailer decides to sell infant formula, it offers a warranty on the product to every parent who trusts its shelves and shares responsibility for harmed babies if the product turns out to be contaminated.
For over 30 years I have been representing families who are on the wrong side of food that should not be sold. And this report follows the oldest pattern I know of. This means that contaminated ingredients travel through multiple companies, and the moment a baby gets hurt, they all point to the next link.
I don’t care about that game and you shouldn’t either. Tracing this outbreak honestly, it follows a straight line from the farm that supplied the Organic West milk, to the Dairy Farmers of America plant in Fallon, Nevada, that turned the milk into powder, to the ByHeart and Blendhouse plants in Iowa that made the powder base, to the Portland plant that sealed it in cans, all the way to grocery store shelves and online carts within reach of parents.
The FDA warned the industry as a whole in March 2023 that Clostridium botulinum was a known risk in powdered infant formula, and that ingredient suppliers who supply milk without lethal treatment were, in the agency’s words, “an extension of the infant formula manufacturing process.”
Every company in that line ultimately has a duty to its children, and strict product liability laws hold it accountable to all of them. 48 babies from 17 states couldn’t decide which company to take sides with. They have to answer, they have to take responsibility, they have a debt that this chain was created to deliver, but failed to deliver. This is a can of powdered milk that is safe to feed to your baby. From milk to shelves, it was everyone’s job. And these babies are everyone’s responsibility.
