A charity in the United Kingdom has made several recommendations to regulators after the cereulide infant formula contamination incident.

First Steps Nutrition Trust said the situation exposed important weaknesses in the safety and security systems governing infant foods.

Contaminated products may have been on the market from May 2025 until the first Food Standards Agency (FSA) alert on Jan. 5, 2026. This raises questions about the adequacy of existing regulatory oversight, surveillance and incident response, said the public health nutrition charity.

Several children have needed hospital treatment in Israel after consuming contaminated fruit puree.

According to the Ministry of Health’s epidemiological investigation, children were hospitalized after having "Prinok" baby fruit puree purchased at Zol U'Begadol stores. At least four children are affected but they have since been discharged.

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

World Food Safety Day was held on June 7. In this article, Food Safety News looks at some of the ways different regions and stakeholders marked the occasion.

On June 8, the UN Food and Agriculture Organization (FAO) held a hybrid event on how Codex texts can help tackle foodborne antimicrobial resistance (AMR).

Fry Pie Factory has issued a recall of its 5-ounce pepperoni rolls because of misbranding involving undeclared milk, a known allergen, and a process deviation related to refrigeration.

The company said the Pepperoni Rolls were not stored, distributed or sold at appropriate temperatures, which may allow pathogenic growth and pose a risk of food-borne illness.

The recalled products were distributed by Fry Pie Factory throughout Ohio and parts of West Virginia in convenience stores, grocery stores and gas stations. The company's recall notice did not include any labeling codes.

No illnesses have been reported. However, consumers with an allergy or severe sensitivity to milk may risk a serious or life-threatening allergic reaction if they consume the product. Anyone experiencing signs of an allergic reaction or food-borne illness should contact a health care provider immediately.

Consumers should discard the Pepperoni Rolls or return them to Fry Pie Factory for a full refund.

Power Plate Meals LLC a West Fargo, ND, Cooperative Interstate Shipping establishment, is recalling 5,795 pounds of frozen meatloaf with garlic mashed potatoes because of misbranding and an undeclared allergen, the USDA's Food Safety and Inspection Service (FSIS) announced today. 

The product contains soy, a known allergen, which is not declared on the product label. People with a sensitivity or allergy to soy run the risk of severe reaction including death if they consume the product.

The frozen meatloaf with garlic mashed potatoes items were produced June 25, 2025, to June 10, 2026. 

FSIS is concerned that some product may be in consumers' freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

The following product is subject to recall:

• 13.3-ounce vacuum sealed plastic tray packages containing "POWER PLATE MEALS MEATLOAF WITH GARLIC MASHED POTATOES" and "USE BY" dates between 6/25/26 and 6/10/27.

The products subject to recall have the establishment number "217SEND" inside the USDA mark of inspection. These items were shipped to distributors in Minnesota, North Dakota and South Dakota.

The problem was discovered when a state inspector notified FSIS that the final label did not contain soy in the ingredients list.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Officials with Nara Organics continue to refuse to report the manufacturer of their infant formula, which has been linked to an outbreak of infant botulism.

However, a German company's website reveals that Milchwerke Mittelelbe GmbH  — also known by its brand name Elb-Milch, a subsidiary of the Krüger Group — is the manufacturer of Nara Organics infant formula. 

The German Milchwerke Mittelelbe GmbH has been part of the Krüger Group since 1991, according to the Krüger website. Krüger specializes in the production of infant nutrition, coffee whitener, basic cocoa and cappuccino products, sweeteners, milk powder and special products for the food industry.

The manufacturer uses milk from 100 contract farmers who supply Milchwerke Mittelelbe with more than a million liters of milk every day.

The outbreak of infant botulism has sickened three babies from California, Pennsylvania and Washington, according to the Food and Drug Administration. They ranged in age from 2 to 5 months old when their illness began. All three consumed Nara Organics Whole Milk Organic Infant Formula. 

All three infants have been hospitalized and treated with BabyBIG®, the FDA-approved treatment for infant botulism. No deaths have been reported.

The California Department of Public Health reported that the infections are among infants who were fed Nara Organics Whole Milk Organic Powdered Infant Formula. The babies became sick in April and May.

The implicated organic formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.

Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks. 

The FDA contacted the firm and recommended that it conduct a recall due to the severity of illnesses and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula. The FDA warns that consumers should not use the recalled infant formula.

Affected product details:

• Nara Organics Whole Milk Infant Formula, 700g, with UPC 860013251901
• Nara Organics Whole Milk Infant Formula, 400g, with UPC: 860013251918

All lots currently on the market are included in this recall, and the specific codes are as follows. The lot code can be found on the bottom of each can.

• 408125075E14F2
• 708125076E14F2
• 708125083E14F2
• 408125139E14F2
• 708125141E14F2
• 708125145E14F2
• 708125174E14F2
• 709125273E14F2
• 709125280E14F2
• 709125288E14F2
• 409125307E14F2
• 70926019ENNB
• 70926029ENNB
• 70926035ENNB
• 70926039ENNB
• 70926042ENNB

Nara Organics Whole Milk Organic Infant Formula makes up less than 1 percent of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers, according to the FDA.

Seven people have fallen ill in Slovakia after eating cheese from an unregistered operation.

Sick people were infected with Salmonella Schleissheim and several of them were hospitalized.

The Regional Veterinary and Food Administration (RVPS) of Liptovský Mikuláš received a complaint from the Regional Public Health Authority (RÚVZ) based in the same area. The incident was reported by the State Veterinary and Food Administration of the Slovak Republic (ŠVPS SR).

Patients consumed products from an operation that the RVPS had no information about. It was not approved and there was no registered sheep breeding at the site.

Inspection findings
Inspectors went to the location in a difficult-to-access forest environment. The owner sold a range of fresh and smoked cheese products to officials. He was later informed that it was an inspection. The visit revealed items were produced and kept in unsuitable hygienic conditions in a wooden shed.

Inspectors found cheese stored in an old wardrobe intended for clothes, smoked cheese in a plastic shopping bag, and products stored at almost 23 degrees C (73.4 degrees F) with no protection from insects and other pests. Tools and equipment were also dirty and inadequate. Curds used in cheese making were dried on a rack and a nearby stream was used as a water source.

Although the owner used gloves when cutting cheese, they were more to protect his hands from getting dirty than to ensure food hygiene, said authorities.

Inspectors took samples from products for microbiological examination. Remaining products were destroyed to protect consumer health. Salmonella and high levels of coagulase-positive staphylococci were detected in cheese.

RVPS imposed a ban on the production and marketing of products from the site and a health examination of the owner to exclude Salmonella carrier status. The owner has been stopped from operating and is facing a fine.

Authorities warned that purchasing food, especially of animal origin, from illegal operations poses a high risk to health. The public was encouraged to pay attention to cleanliness and hygiene conditions, the method of storing products, food handling, and the availability of information on origin and approval.

Consumers can check whether a product comes from an approved sheep farm under veterinary control by searching for the establishment in the list of approved sites on the ŠVPS SR website or by checking the identification mark on the product.

-- OPINION --

In food safety litigation, one of the most consequential, and often most contested, questions is not whether a product was contaminated, or even whether someone was harmed. It is whether the court has the power to hold the right defendants accountable in the first place. That question, always important, has taken on new urgency in light of a Salmonella outbreak linked to a greens-style dietary supplement that has now sickened at least 119 people across 36 states. As that litigation unfolds, a 2023 decision from the Southern District of New York — Albright v. Daily Harvest, Inc., No. 22cv5987, 2023 U.S. Dist. LEXIS 151783 (S.D.N.Y. Aug. 25, 2023) — has emerged as a significant and directly relevant precedent for how courts approach supply chain accountability in food safety cases.

Background: The Daily Harvest outbreak
Readers of Food Safety News will remember the 2022 Daily Harvest outbreak. Daily Harvest, a subscription-based health food company with its principal place of business in New York, sold a product called French Lentil + Leek Crumbles that was linked to serious liver injuries in consumers — elevated liver enzymes, jaundice, and in some cases surgical intervention. The culprit ingredient was tara flour, produced by a Peruvian corporation called Molinos Asociados SAC.

The supply chain was layered: Molinos sold its tara flour to a U.S.-based distributor, which supplied it to a Minnesota contract manufacturer, which incorporated it into the finished product for Daily Harvest. When plaintiffs brought suit in the Southern District of New York — the logical forum, given Daily Harvest’s New York headquarters — Molinos moved to dismiss for lack of personal jurisdiction. It argued that it was a Peruvian company that had never entered New York, maintained no office or facility there, and had no direct contractual relationship with any New York entity.

District Judge Denise Cote denied the motion in August 2023. My firm, Marler Clark, represented the majority of the plaintiffs in the class action litigation and successfully opposed the motion. Judge Cote’s opinion merits careful study.

What the Court Found
Judge Cote’s analysis centered on New York’s long-arm statute, CPLR § 302(a)(1), which permits a New York court to exercise personal jurisdiction over any non-domiciliary that “transacts any business within the state or contracts anywhere to supply goods or services in the state.” The statute is a “single act” statute; even one transaction with sufficient New York connections can be enough, even if the defendant never physically entered New York.

The critical facts were these. Molinos’s purchase order from the U.S. distributor explicitly required that the tara flour match Daily Harvest’s specifications —meaning Molinos understood precisely whose product requirements governed its manufacturing. The logistics documentation identified New York-based entities as participants in the importation chain. Molinos had copied Daily Harvest employees on email correspondence about shipping delays. And Molinos’s own internal presentation reflected that it had formally accepted Daily Harvest’s specifications through a supply chain management platform that identified Daily Harvest as a New York company.

Assessing the totality of that evidence, Judge Cote concluded that Molinos had “purposefully engaged with Smirk’s and Daily Harvest as it sold its tara flour for use in the manufacture of a product it understood would be sold by Daily Harvest, a New York company.” That purposeful commercial engagement, shaped by and directed at a New York entity, was sufficient to establish personal jurisdiction. The motion was denied.

Why the decision matters
The Daily Harvest ruling matters for reasons that extend well beyond the tara flour litigation.

First, it firmly establishes that physical presence in New York is not required for personal jurisdiction under CPLR § 302(a)(1). A foreign or out-of-state supplier that knows it is manufacturing to the specifications of a New York company, and that shapes its commercial conduct accordingly, has purposefully availed itself of the privilege of doing business connected to New York, even if its product never crossed the state line while in the supplier’s possession. The commercial relationship and the knowledge it reflects are what matter, not the geography of the production facility.

Second, the decision gives practical content to the “nexus” requirement of § 302(a)(1). Under the New York Court of Appeals’ controlling formulation in Licci v. Lebanese Canadian Bank, a plaintiff’s claim need only have “a relatedness” to the defendant’s New York-directed business activity such that it is “not completely unmoored” from that activity. Daily Harvest applies this standard in a multi-party supply chain context and establishes that contamination claims arising from an ingredient supplied for a New York company’s product satisfy the nexus requirement — even when multiple commercial intermediaries stand between the supplier and the forum.

Third, the decision signals that courts will look at the totality of a supplier’s commercial relationship with a New York entity. Suppliers who understand themselves to be serving a New York company, and conduct themselves accordingly, cannot disclaim that relationship for jurisdictional purposes when harm results.

The ongoing moringa outbreak: A stronger set of facts
The Daily Harvest decision has direct application to litigation arising from a Salmonella outbreak that, as of the most recent FDA update on June 12, has grown substantially since it first came to public attention in January. Litigation involving this outbreak is ongoing, and I will not identify specific parties, clients, or confidential case information. But the public record — and it is substantial — tells an important story.

As of May 27, 119 people have been sickened across 36 states and 32 have been hospitalized. The investigation was opened in January 2026, briefly closed, then reopened after 22 new illnesses emerged, suggesting contaminated product remained in circulation longer than initially understood. Traceback investigations have confirmed moringa leaf powder, contaminated with Salmonella Typhimurium and Salmonella Newport, as the source, with multiple recalls covering a greens-style supplement and two additional moringa capsule product lines linked to the same manufacturer.

The jurisdictional posture of this litigation parallels Daily Harvest in important ways, and in some respects presents a stronger case. In Daily Harvest, the upstream supplier’s connection to the New York forum ran through an intermediary chain: a Colorado distributor and a Minnesota manufacturer stood between the Peruvian flour producer and the New York brand owner. The supplier’s knowledge of the New York connection was established through logistics documents, copied emails, and specification compliance records.

In the moringa supplement litigation, at least some of the relationships at issue are direct: written agreements between the contract manufacturer and the New York brand owner, bearing the New York address on their face; product samples mailed to New York; commercial communications directed to New York; purchase orders issued from a New York address and invoices sent to a New York billing address. Where Daily Harvest established jurisdiction based on an indirect, intermediary-mediated relationship, the current litigation involves direct contractual ties of the kind that make the purposeful availment analysis considerably more straightforward.

The broader lesson: Supply chain length is not a defense
Civil litigation is one of the most powerful mechanisms available for holding the supply chain accountable, but only if the responsible parties are actually in court. None of that happens if upstream suppliers can obtain jurisdictional dismissals before a single document is produced.

Daily Harvest makes those dismissals harder to obtain, at least when the upstream supplier had a purposeful, documented commercial relationship with a New York entity. It stands for the proposition that the length of the supply chain is not, by itself, a jurisdictional defense. A supplier that understands itself to be serving a New York company — that meets that company’s specifications, coordinates with New York-based logistics partners, and directs commercial communications to New York-based personnel — has transacted business in New York in the sense that § 302(a)(1) requires. The fact that other commercial actors stand between the supplier and the end consumer does not change the analysis.

A final observation
The moringa outbreak is not over. As of April 2026, 32 people have been hospitalized and new illnesses were still being reported more than a year after the first cases emerged. The people sickened are not interested in legal abstractions about minimum contacts and purposeful availment. They are trying to hold accountable those responsible for placing a contaminated product into their hands. Daily Harvest matters because it ensures that mechanism remains available—that jurisdiction does not become a shield protecting upstream suppliers from accountability.

The supply chain is not a shield. The courts, it appears, are taking that principle seriously.

Dietary exposure to inorganic arsenic represents a major problem, according to an analysis of foodborne chemicals.

In 2021, nine foodborne chemicals caused 6.26 million cases and 1.12 million deaths. These substances are inorganic arsenic, lead, aflatoxin B1 and M1, methylmercury, cadmium, dioxin, peanut allergy, and cassava cyanide.

The U.S. company that sold infant formula related to the most recent outbreak of infant botulism imported the product from Germany.

However, Nara Organics has not named the specific manufacturer of the formula.

“Nara works with a state of the art manufacturer in Germany who has over 70 years of experience making top European infant formulas,” a company spokeswoman told Food Safety News.

The spokeswoman has neither responded to questions about the name of the German manufacturer nor provided comment about why the name is being withheld from the public.

So far the outbreak has sickened three babies across three states, California, Pennsylvania and Washington, according to the Food and Drug Administration. They ranged in age from 2 to 5 months old when their illness began. All three consumed Nara Organics Whole Milk Organic Infant Formula. 

All three infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for infant botulism. No deaths have been reported.

A U.S. representative issued a statement on June 16 calling on Congress to pass the bipartisan Infant Formula Safety Modernization Act.

“In just seven months, we have experienced two outbreaks of infant botulism tied to powdered infant formula. First, a ByHeart outbreak which sickened 48 sick babies across 19 states, and now Nara Organics with babies in three different states – all of them between two and five months old – now fighting for their lives,” said Rep. Rosa DeLauro, D-CT. 

“This is not an isolated incident, it is a concerning pattern that begs the question; are we doing enough to ensure the safety of infant formula in this country? Before ByHeart and Nara Organics, in 2022, there was Abbott’s facility in Sturgis, MI, that shutdown after a cronobacter sakazakii outbreak, triggering a nationwide shortage that left families scrambling for formula and babies hospitalized and in some cases, dead. 

“The food we give our babies must meet the highest standard of safety. Right now it does not, and the gaps in the system are clear. Multiple crises year after year show the current system is not working, and we must be doing more.” 

The Infant Formula Safety Modernization Act is endorsed by the American Academy of Pediatrics, Consumer Reports, Prolacta, Consumer Federation of America, Environmental Working Group, Center for Science in the Public Interest, STOP Foodborne Illness, and the Association of Public Health Laboratories.

The outbreak and recall
The California Department of Public Health reported that the infections are among infants who were fed Nara Organics Whole Milk Organic Powdered Infant Formula. The babies became sick in April and May.

The implicated organic formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.

Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks. 

The FDA contacted the firm and recommended that it conduct a recall due to the severity of illnesses and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula. Consumers should not use recalled infant formula.

Affected Product Details:

• Nara Organics Whole Milk Infant Formula, 700g, with UPC 860013251901
• Nara Organics Whole Milk Infant Formula, 400g, with UPC: 860013251918

All lots currently on the market are included in this recall, and the specific codes are as follows. The lot code can be found on the bottom of each can.

• 408125075E14F2
• 708125076E14F2
• 708125083E14F2
• 408125139E14F2
• 708125141E14F2
• 708125145E14F2
• 708125174E14F2
• 709125273E14F2
• 709125280E14F2
• 709125288E14F2
• 409125307E14F2
• 70926019ENNB
• 70926029ENNB
• 70926035ENNB
• 70926039ENNB
• 70926042ENNB

 Nara Organics Whole Milk Organic Infant Formula makes up less than 1 percent of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers, according to the FDA.

Thoughts from a food safety expert
Seattle food safety attorney Bill Marler said the pattern is more than troubling.

"We have been here before,” Marler said. “In March 2023, the FDA told this entire industry, in writing and naming Clostridium botulinum, that powdered infant formula had a documented history of botulism and that manufacturers had to control for it. None of this was unforeseeable. It was preventable.

“Three babies are in the hospital. Mercifully, no one has died. But a recall after the fact is not a food safety system — it is a bad apology. After the ByHeart outbreak, the FDA had to send warning letters to Target, Walmart, Kroger and Albertsons because recalled infant formula was still sitting on store shelves — in some cases restocked and discounted — weeks after the recall began. So, I want to know what has changed. I want to know why we test finished formula for botulism only after babies get sick instead of before a single can ships. And I want to know why, when a baby survives a formula-related illness, the manufacturer is under no obligation to tell the FDA at all.

“My firm represents more than twenty other families whose infants were poisoned in the ByHeart outbreak — the first formula-linked infant botulism outbreak ever recognized. I have spent more than thirty years sitting with parents on the worst day of their lives, and there is nothing abstract about an infant on a ventilator. If you have this formula in your home, stop using it today — but keep the container, because your health department may need it. And if your baby is feeding poorly, can’t hold up their head, or seems unusually weak or floppy, do not wait. Call your doctor now.”

For more information about FDA’s ongoing efforts to ensure the safety of infant formula please see FDA’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.  

On Thursday, June 11, 2026, the FDA quietly posted to its website the document those of us investigating the ByHeart infant-botulism outbreak have waited months to see: the complete Establishment Inspection Report (EIR) for Blendhouse Allerton, LLC — the Iowa plant that produced ByHeart’s infant-formula base powder.

Credit where it is due: Bloomberg’s Anna Edney was first to flag the release, reporting that federal inspectors found no evidence ByHeart’s own production “caused” the outbreak and pointed instead toward contaminated ingredients. You can read her piece here: FDA Finds No Evidence ByHeart Production Caused Infant Formula Botulism Cases. She is right — but a 55-page government report holds far more than any headline can, so I read all of it.

So can you. Here is the actual source 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 a different and much longer document than the three-page Form FDA 483 that was issued back in January. The 483 is simply Attachment 1 to this report. The narrative, the findings, and FDA’s conclusions live in the EIR — and the EIR is what went public Thursday.

What the FDA actually concluded:

After weeks on site, FDA’s investigators wrote, on page 35, that the genetic match between the Clostridium botulinum–positive ingredients and both a sick infant and a previously manufactured finished product “appears to indicate that raw materials were more likely the source of the outbreak than the firm’s processing equipment and storage practices.”

In plain English: the spores most likely rode in on an ingredient.

That ingredient is organic whole milk powder. The report lays out how, on January 21, 2026, ByHeart’s VP of Quality told FDA that lots of organic whole milk powder had tested presumptive-positive for C. botulinum, and that one isolate matched both a clinical sample from a sick baby and a ByHeart finished product (pp. 31–32). The CORE team identified organic whole milk powder as “an ingredient of concern” (p. 34). FDA collected a dozen base-powder samples tied to the recalled finished lots — 251131P2, 251261P2, 251481P2, and 243201P2 — and shipped them out for botulinum testing (pp. 47–48).

Follow the milk: Organic West Milk → Dairy Farmers of America → Organic West Milk → ByHeart

The EIR redacts the supplier names, but the supply chain is no longer a secret. As the Associated Press’s Jonel Aleccia first reported, the organic whole milk powder was made from fluid organic whole milk supplied by Organic West Milk, Inc., a California company that pools milk from 55 farms, and was dried into powder at a Dairy Farmers of America (DFA) plant in Fallon, Nevada. DFA dried the milk for Organic West Milk, Inc., that sold the powder to ByHeart, and the lot FDA collected at the DFA plant genetically matched the outbreak strain.

So, the chain runs like this:

• Fluid whole milk — Organic West Milk, Inc. (California, 55 farms)
• Powdered whole milk — Dairy Farmers of America, Fallon, Nevada (dries the milk)
• Infant-formula base powder — ByHeart at Blendhouse Allerton, Iowa
• Finished, canned formula — ByHeart’s Blendhouse Portland, Oregon plant
• The Retailers — the stores that sold the can to a parent

The agency was looking hard upstream: FDA’s investigators collected “Audit Observations at DFA” as Exhibit 81 (p. 51), alongside ingredient tracebacks. 

And the finger-pointing has predictably begun — ByHeart points upstream, DFA has emphasized that the maker of the end product bears responsibility to properly process ingredients for safety, while Organic West’s owner has suggested something went wrong in turning milk into powder and powder into formula. Everyone in the chain is pointing at the next link.

What “the ingredients did it” does not mean:

Here is where I want to be very clear, because the spin will be loud: identifying a contaminated milk ingredient does not get ByHeart off the hook. Not legally, and not morally.

Blendhouse Allerton is the sole producer of the base powder used in ByHeart’s formula (p. 1). And the very same report that points upstream also handed ByHeart a fresh three-item Form 483 (pp. 41–44):

• A process-intrusion flush that was never documented after black rubber pieces were found in the line, with no rationale recorded — 21 CFR 106.50(a)(1);
• A finding that the firm did not ensure all ingredient-contact surfaces were cleaned and sanitized — specifically, an oil storage silo that did not receive the second caustic wash its own procedure required — 21 CFR 106.30(b); and
• A base mix that dropped below its required temperature and was fed forward with no management approval, where the firm failed to evaluate the public-health significance of the deviation — 21 CFR 106.6(c)(4).

Worse, two observations from the February 2025 inspection were carried into this report as still “Not Corrected”: failing to maintain the building in a clean and sanitary condition (21 CFR 106.20(a)) and approving and releasing an ingredient that was not held under conditions to prevent adulteration (21 CFR 106.40(f)(3)) (pp. 2–3). Read that last one again. Months before babies got sick, FDA had already cited this plant for releasing an ingredient that wasn’t held under conditions to prevent adulteration — and at the time of this outbreak report, it still wasn’t fixed. And look at what that February 2025 inspection actually found. Its very first observation named the exact ingredient now at the center of this outbreak: FDA cited the plant for receiving and releasing whole organic dried milk powder that was not held under conditions to prevent adulteration (p. 1). The same inspection faulted the firm for failing to eliminate rodent-harborage areas after rodent problems in 2024–2025, and for not adequately monitoring the dryer floor after findings of confirmed Cronobacter sakazakii — a pathogen that can be deadly to infants and that drove the massive 2022 Abbott formula recall (pp. 1–2). This plant was already on notice about the milk, about the rodents, and about a baby-killing organism at its dryer, months before a single child got sick.

And then the central point: Clostridium botulinum spores in dairy are a known, foreseeable hazard. The entire job of an infant-formula manufacturer is to control the hazards in the ingredients it buys — because the end product goes into the most vulnerable humans on earth, whose immature guts allow those spores to germinate and produce toxin. ByHeart’s own June 10 “action plan” now promises C. botulinum-specific testing of every dairy ingredient and every finished batch before release. That is a tacit admission that this hazard was testable and controllable all along. You do not get credit for installing the smoke detector after the house has burned down. Nor was the hazard hypothetical at this plant. In January 2025, BHA’s own records (SNC25-002-BHA) document pallets of organic whole milk powder arriving with visible gnaw holes, spilled powder, and potential rodent droppings (p. 15) — rodent contamination on the very ingredient that carries C. botulinum spores. FDA ultimately concluded those particular contaminated pallets were not the source of this outbreak — they involved different lots received at a different warehouse (p. 35) — but that misses the larger point. A plant that has already watched gnawed, soiled bags of milk powder come through its doors knows exactly how filth rides in on this ingredient, and exactly why every lot of it must be controlled before it ever reaches a baby.

The bottom line:

Forty-eight infants were hospitalized across seventeen states. None died — but botulism can leave lasting harm, and these are babies. The FDA report does real and important work tracing the spores to a milk-powder ingredient and to the companies that supplied and processed it. Organic West Milk and Dairy Farmers of America will have to answer for the lot that carried the outbreak strain, and they should. The scale of the danger is in the report itself: the recall began with two lots on November 8, 2025, grew to every lot of ByHeart formula by November 19, and FDA classified it Class I — the agency’s most serious category, reserved for products that can cause serious injury or death. It was still ongoing when inspectors closed this report (pp. 8–9).

But a company that puts its name on a can of infant formula — that markets it as the closest thing to breast milk — cannot outsource responsibility for what is inside that can. ByHeart chose its suppliers, bought the ingredient, made the base powder, and sold the product to parents who trusted it. Pointing at the milk explains how the spores got in. It does not change who was responsible for keeping them out. The buck — and the baby’s bottle — stopped with ByHeart.

And the responsibility does not stop at ByHeart. Every company that sold this formula to a family is part of the chain of distribution of an adulterated, dangerous product — and under long-settled product-liability law, sellers in that chain can be held strictly liable for placing it into a parent’s hands, whether or not they knew what was in the can. The grocery chains, pharmacies, big-box stores, and online sellers that stocked and shipped recalled ByHeart formula profited from moving this product to the most vulnerable consumers there are. That carries a legal duty, and it carries a moral one. When a retailer chooses to sell infant formula, it vouches for that product to every parent who trusts its shelves — and when the product turns out to be contaminated, it shares in the responsibility to the babies who were harmed.

I have spent more than thirty years representing the families on the wrong end of food that should never have been sold — and this report follows the oldest pattern I know: a contaminated ingredient travels down a chain of companies, and the moment babies are hurt, every one of them points at the next link. 

I am not interested in that game, and neither should you be. Trace this outbreak honestly and it runs in a straight line — from the farms that supplied Organic West Milk, to the Dairy Farmers of America plant in Fallon, Nevada that dried that milk into powder, to ByHeart and its Blendhouse plant in Iowa that turned the powder into base, to the Portland plant that sealed it into a can, to the grocery shelves and online carts that put it within a parent’s reach. 

FDA warned this entire industry, by name, in March 2023 that Clostridium botulinum was a known hazard in powdered infant formula — and that an ingredient supplier whose milk receives no lethal treatment is, in the agency’s words, “an extension of the infant formula manufacturing process.” 

Every company in that line had a duty to the child at the end of it, and the law of strict products liability holds every one of them to it. Forty-eight babies in seventeen states had no say in which of these companies cut which corner. They are owed answers, they are owed accountability, and they are owed the one thing this chain was built to deliver and did not: a can of formula that was safe to feed a baby. From the milk to the shelf, that was everyone’s job — and these babies are everyone’s responsibility.

Five people have fallen sick after eating food sold at a Costco store in Japan.

Earlier this month, the Nagoya City Public Health Center received a report of a person infected by E. coli. After investigating, it was found that the patient had eaten food prepared at the Costco Wholesale Moriyama Warehouse Store.

Further inquiries revealed that five people who consumed food made and served at the site between May 31 and June 1 had symptoms of food poisoning, including diarrhea, abdominal pain, and fever. Patients range in age from 7 to 49 years old.

E. coli O157 was detected in stool samples from all five patients. The suspected product name is the High Roller bacon lettuce tomato (BLT) wrap.

The Nagoya City Public Health Center has issued a suspension order to the restaurant and food manufacturing businesses that were involved in the preparation of contaminated food at the store.

In a statement, Costco Japan said: “We have received reports of illness from some members who consumed 'High Roller' products manufactured and sold at the Moriyama Warehouse Store's delicatessen corner on May 31 and June 1. An investigation revealed the presence of E. coli O157.

“We sincerely apologize to affected members and their families for the great distress and worry caused. We are currently fully cooperating with the public health center's investigation and have re-emphasized our safety management system based on their guidance.”

Costco said it had cleaned related equipment and brought in an external company to disinfect the food manufacturing area. "High Roller" products made on May 31, or June 1, have also been recalled.

The Japan Institute for Health Security (JIHS) published a special feature on E. coli infection earlier this year.

According to the Infectious Disease Outbreak Trend Survey, in 2025, 2,472 symptomatic E. coli infections and 1,866 asymptomatic cases – detected through epidemiological surveys or regular stool tests by food workers – were reported. Overall, the 4,338 cases is the highest figure since 2011.

There were 59 cases of hemolytic uremic syndrome (HUS) and E. coli was isolated from 46 cases. Of these, O157 was detected 41 times. Ten incidents of E. coli food poisoning were reported to the Ministry of Health, Labour and Welfare in 2025 with 362 patients. 

A complaint has been raised relating to the European Commission’s handling of planned legislation, claiming it could have consequences for food safety standards.

The Food and Feed Safety Omnibus package includes rules on pesticide residues, border controls on food imports, and adapted bovine spongiform encephalopathy (BSE) surveillance. 

Example E. coli and Salmonella outbreaks are included in a review by the UK Health Security Agency (UKHSA) of health risks that could occur in the next few years.

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For the topics listed, a reasonable worst-case scenario is created. The impact of each risk on public health, healthcare systems, and wider society is measured, alongside the likelihood of each one occurring, to help with planning and risk mitigation.