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Marler Blog

Marler Blog

Nationally recognized food poisoning attorney and food safety advocate Bill Marler provides commentary on E. coli, Salmonella and Listeria outbreaks and other food safety topics.

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RETAIL SHOPPING AND CONSUMER AFFAIRS

E. coli O26 Outbreak Linked to Sierra Nevada Cheese Company’s Graziers Raw Milk Cheese: 13 Sick in Nine States, 8 Hospitalized, 3 with HUS — Most Are Children 5 and Under

On Friday, September 25, the CDC and FDA announced that a multistate outbreak of Shiga toxin-producing E. coli O26:H11 has been linked to Graziers grass-fed raw milk cheese made by Sierra Nevada Cheese Company of Willows, California. Thirteen people in nine states are sick. Eight have been hospitalized, and three have developed hemolytic uremic syndrome (HUS), the kidney failure that follows some E. coli infections. No one has died. The median age of the sick is 5, and more than half of them are children age 5 or younger. All four Graziers raw milk varieties — medium cheddar, sharp cheddar, jalapeño jack and Monterey jack — have been recalled. They were sold nationwide, in stores and online, in 8-ounce and 16-ounce packages and in 5-pound loaves to restaurants, delis and wholesalers. The cheese has a long shelf life. If any of it is in your refrigerator or freezer, do not eat it. The numbers, as of September 25 CDC’s count: - 13 confirmed illnesses in nine states: California (3), Nevada (3), and one each in Colorado, Georgia, Kentucky, Michigan, Oregon, Tennessee and Utah. - 8 hospitalized — 62 percent of the people with information available. - 3 cases of HUS. - 0 deaths. - Ages range from 1 to 58, with a median of 5. Sixty-two percent are female. - Illnesses began between July 7 and August 26, 2026 — six in July and seven in August. Nine sick people or their caregivers have been interviewed, and all nine reported eating Graziers raw milk cheese. For comparison, only 4.9 percent of respondents in CDC’s FoodNet Population Survey report eating raw milk cheese in a given week. Whole genome sequencing shows the bacteria from the sick people are closely related, which means they share a common source. San Diego County reports that two of California’s three cases are San Diego County children under 5. The timeline matters. The first illness began on July 7; FDA did not contact the company until September 24, more than eleven weeks later. That lag is not unusual — CDC says it typically takes three to four weeks to link a sick person to an outbreak — but with a long-shelf-life cheese it means recalled product is almost certainly still sitting in homes, and CDC says the true number of sick people is likely much higher than 13. The recall FDA notified Sierra Nevada Cheese Company of the outbreak on September 24 and recommended a recall. The company agreed the same day and recalled all Graziers raw milk cheeses. In a statement posted to social media, the company said the illnesses have been associated with its medium cheddar, but that it is recalling every Graziers raw milk cheese on the market because the investigation has not narrowed to a specific lot or date code. That means there are no codes to check: every package of the four varieties is in the recall. The 5-pound loaves are a particular problem. Cheese sold in bulk to food service and wholesale customers gets cut, re-wrapped and sold under a store’s own label, and FDA has told retailers that repackaged it not to sell it. If you bought cut raw milk cheddar or jack from a deli or cheese counter this summer and cannot tell where it came from, throw it out. FDA says its investigation into the source of the contamination, and into whether other products are affected, is ongoing. This is not the company’s first problem with raw milk. In August 2025, California’s State Veterinarian ordered a statewide recall and quarantine of Sierra Nevada’s Bella Capra raw goat milk cheddar after California Department of Food and Agriculture testing found Listeria monocytogenes in the cheese. “Aged 60 days” is not a kill step Raw milk cheese is legal to sell across state lines. FDA’s standards of identity for cheddar (21 CFR 133.113) and Monterey jack (21 CFR 133.153) allow unpasteurized milk if the cheese is cured at not less than 35°F for at least 60 days — a rule adopted in 1949 on the theory that acid, salt and time would finish off whatever pasteurization was not there to kill. FDA has known for a decade that the theory does not hold. Beginning in 2014, it tested 1,606 aged raw milk cheeses because, in its own words, evidence indicated that 60 days of aging may not eliminate or adequately reduce disease-causing bacteria. It found Salmonella, Listeria monocytogenes and Shiga toxin-producing E. coli, each in under one percent of samples, and generic E. coli, the indicator of insanitary processing, in 5.4 percent. Then it stopped large-scale sampling. The outbreak record since then is what the sampling predicted. Every one of these cheeses met the 60-day rule: - February 2024 — Raw Farm, LLC (Fresno, California), raw cheddar, E. coli O157:H7: 11 sick in five states, 5 hospitalized, 2 with HUS. - October 2025 — Twin Sisters Creamery (Ferndale, Washington), aged raw milk cheese, E. coli O103 and O26: 10 sick in Washington and Oregon, 1 hospitalized. The Washington State Department of Health noted the cheese “is aged at least 60 days, as required by law.” (I represent a claimant in that outbreak.) - March 2026 — Raw Farm again, raw cheddar and raw milk, E. coli O157:H7: 9 sick in three states, 3 hospitalized, 1 with HUS. Over half the sick were children under 5. - September 2026 — Sierra Nevada Graziers, E. coli O26:H11: 13 sick in nine states, 8 hospitalized, 3 with HUS. Over half are age 5 or younger. Four outbreaks in a little over two and a half years: 43 people sick, 17 hospitalized, at least six with HUS, all from cheese that complied with federal law. The same O26 serogroup that is sickening people now turned up in the Twin Sisters cheese last fall. This is no longer a story about one bad dairy. What FDA needs to do I have been working on a citizen petition to FDA under 21 CFR 10.30 asks for two things. First, a prescribed warning statement on cheese made from unpasteurized milk, added to 21 CFR 101.17 — the same regulation that has required a warning on unpasteurized juice since 1998, after a child died in the 1996 Odwalla E. coli O157:H7 outbreak, and a safe-handling statement on shell eggs. The warning would have to travel with the cheese, onto cut-to-order pieces, imports and online listings, because a parent at a deli counter cannot read the fine print on a 5-pound loaf that was cut and re-wrapped in the back. Second, FDA should finish the reevaluation of the 60-day rule that it announced in 2013, when it released the joint FDA/Health Canada listeriosis risk assessment, and has never completed. CDC’s advice in this very outbreak is to choose pasteurized milk and dairy products, and that doing so “is especially important for children under 5.” FDA and CDC already say that on their websites. The petition asks them to say it on the package, where a parent will see it. What to do now - Check your refrigerator and freezer for Graziers medium cheddar, sharp cheddar, jalapeño jack or Monterey jack. Throw it away or return it for a refund. If you stored raw milk cheese without its original packaging and cannot identify it, throw it away. - Wash and sanitize anything the cheese touched: cutting boards, knives, containers and refrigerator shelves. - Watch for symptoms. E. coli O26 usually causes severe stomach cramps, diarrhea that is often bloody, and vomiting, beginning three to four days after eating the contaminated food and sometimes as late as nine days. Call a doctor for bloody diarrhea, a fever above 102°F, diarrhea lasting more than two days, vomiting that keeps you from holding down liquids, or signs of dehydration. - In young children, watch for the signs of HUS: urinating less often, unusual tiredness, and losing the pink color in the cheeks and inside the lower eyelids. Those are emergency-room symptoms. Marler Clark has represented victims of E. coli and HUS since the 1993 Jack in the Box outbreak, including families whose children were sickened in earlier raw milk and raw milk cheese outbreaks. If you or a family member developed an E. coli infection or HUS after eating Sierra Nevada Graziers raw milk cheese, we can be reached at 1-800-884-9840. And if you are wondering whether raw milk cheese is worth it for your family, CDC’s answer this week is the same as mine: choose pasteurized.
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FOOD COOKING AND DINING

FDA, USDA and CDC Are Possibly Working the Same E. coli O157:H7 Outbreak. Twenty-Five People Are Sick, the Product Is Listed as Unknown, and the Shared Reference Number Is the Most Informative Thing on Any of the Three Pages.

Three federal websites are carrying the same outbreak this week, and none of them will tell you what food is in it. On September 23, FDA’s CORE investigations table added reference #1421: E. coli O157:H7, 25 sick, traceback initiated. The entry carries a second number, USDA-FSIS reference 2026-04, and it is the only active row on FDA’s table with a USDA number attached. FSIS’s outbreak table now lists 2026-04 as a September 2026 investigation, pathogen E. coli O157:H7, product Unknown, Active: Yes, with a note that FDA and FSIS are investigating it together. Before this row, FSIS had listed three investigations for all of 2026, every one of them marked closed. This is the fourth, and the only one open. CDC’s page does not list an outbreak until it has something to tell people to do. What it posts is a weekly count of active multistate investigations by germ. This week’s count: six for E. coli, five for Listeria, twenty for Salmonella, one for Campylobacter. CDC does not say which six E. coli clusters those are. Is it the same outbreak? Yes. The two tables point at each other: FDA’s row carries FSIS’s number and FSIS’s row carries FDA’s. FSIS’s own FAQ says an outbreak may appear on both tables when products regulated by both agencies are suspected sources. FDA’s CORE table is, in practice, a multistate table, and FSIS notes that CDC generally works only multistate investigations, so #1421 is almost certainly one of CDC’s six. Almost certainly is as far as the public record lets anyone go. Why is CDC involved? CDC is on every multistate cluster, whatever the food. The cases are matched by whole genome sequencing through PulseNet, the interviews are done by state and local health departments, and CDC coordinates the epidemiology. By its own description, CDC coordinates between 17 and 40 multistate investigations in a typical week, and not all of them produce a public notice. CDC being involved is the default, not the signal. Why are both FDA and USDA on it? This is the part worth understanding, because the two agencies do not share jurisdiction over food. They divide it. FSIS covers meat, poultry and processed egg products under the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. FDA covers everything else under the Food, Drug, and Cosmetic Act. Where a food contains both, a formula decides: products with more than 3 percent raw meat or poultry, or 2 percent or more cooked, are FSIS’s; anything under those thresholds is FDA’s. The line produces results that have been mocked in Congress for twenty years. Cheese pizza is FDA’s; pepperoni pizza is FSIS’s. A packaged open-face meat sandwich is inspected by FSIS and a closed-face sandwich by FDA, and GAO reported in 2001 that the split exists because FSIS lacked the resources to inspect every sandwich maker, so it kept the less common kind. An outbreak lands on both tables when the epidemiology has not settled on one side of that line. FSIS says it posts an active investigation only when there is compelling epidemiologic, sampling or traceback evidence that an FSIS-regulated product is a confirmed or suspected source. It also says that calling a product suspected does not mean other foods were ruled out, and that an investigation can end up implicating a product FSIS does not regulate even when meat or poultry was the first suspect. On FDA’s side, a traceback has to start from something, a product or a point of sale, so FDA has a lead it is not naming. Put the two rows together and they read: the sick people ate something with a meat or poultry component and an FDA component, and neither agency has been able to eliminate its half. There are two ways that happens, and they are different animals. The first is a single mixed product that sits on one side of the line by formula. A chicken Caesar salad kit or a ready-to-eat pasta meal with chicken is an FSIS product on paper, but the contaminated ingredient inside it can be the lettuce, which pulls FDA into the traceback. The last two rows on FDA’s table to carry a USDA number were Listeria outbreaks in prepared pasta meals and ready-to-eat deli foods, both multi-ingredient products. The second is a meal rather than a product. The customer ate a hamburger. The patty is FSIS’s; the lettuce and the onions are FDA’s. For E. coli O157:H7 this is the more likely shape, because its two biggest vehicles, ground beef and leafy greens, sit on opposite sides of the jurisdictional line, and a restaurant signal drags in both agencies at once. What happened the last time it was a hamburger On October 22, 2024, FDA, FSIS and CDC announced a joint investigation of E. coli O157:H7 illnesses in people who had eaten McDonald’s Quarter Pounders and said investigators were working out whether the slivered onions or the beef patties were the source. FDA traced the onions; FSIS traced the patties. The interviews could not separate the two: of the people who could remember what they ordered, 83 percent reported a menu item with slivered onions and 79 percent reported one with a quarter-pound patty. Three people had onions without the patty. One had the patty without onions. By October 30, FSIS reported that its traceback of the patties had not identified a beef source and that Colorado’s testing of the patties was negative, and Taylor Farms’ yellow onions were the likely vehicle. The final count was 104 sick in 14 states, 34 hospitalized and one dead. My firm represented people sickened in that outbreak. The McDonald’s file also shows why the split matters to consumers and not only to lawyers. On the day of the announcement, McDonald’s pulled both the slivered onions and the Quarter Pounder patties from the affected states while the traceback ran. Nobody waited for the tie to be broken, and the public was told which two ingredients were in play. What the public will and will not be told For #1421 there are three doors. CDC posts a notice when there is something actionable to tell people, and it says plainly that not every investigation gets one. FDA posts an advisory when it names an FDA-regulated food. FSIS issues a public health alert or a recall when the evidence lands on meat or poultry. If none of those opens, the file closes the way #1382 did this month: romaine lettuce named only at closure, no grower, no processor, and nothing said while people were still eating it. FSIS’s own answer, on its outbreak page, to what if I want to know more about a specific investigation, is a link to its FOIA office. What I would ask for is modest. Say which states. Say the onset dates. If the suspect is a mixed product, say so, and say which ingredient each agency is tracing, the way FDA and FSIS did within hours in 2024. The McDonald’s outbreak reached 104 people. This one is at 25, and 25 is a floor: a cluster that has produced two federal reference numbers and a traceback has not finished growing. Why I am watching which half of the sandwich it is I spent the first decade of this work suing over hamburger. That business went away because FSIS declared E. coli O157:H7 an adulterant in raw ground beef in September 1994 and the industry built its testing and its liability around that word. My firm’s hamburger cases ran from Jack in the Box in 1993 to the ConAgra recall in 2002 and are now close to zero. Since about 2000, the E. coli cases have mostly been lettuce. The bacteria did not move. The regulator did, and the half of the food supply that got the adulterant standard is the half that nearly stopped sending me clients. When FDA and FSIS both open a file on an O157 outbreak, the question I care about is not only what the food was. It is which side of the line it was on, and whether the regulator on that side has sampled for the bug the way FSIS has sampled ground beef since the fall of 1994.
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AGRICULTURE AND FOOD PRODUCTION

Thirty-Two People in Six States Are Sick with Salmonella from Evergreen Fresh Sprouts Broccoli Sprouts, Ten More People and Two More States Since September 11. Twenty-Five of Them Got Sick Before the First Recalled Bag Was Delivered.

CDC updated its outbreak page today. Thirty-two people in six states are infected with the outbreak strain of Salmonella Bovismorbificans linked to broccoli sprouts grown by Evergreen Fresh Sprouts, LLC of Moyie Springs, Idaho: twenty-four in Washington, four in Montana, and one each in Idaho, Minnesota, Oregon and Utah. Three have been hospitalized. No one has died. Illnesses began between July 7 and September 3. On September 11 the count was twenty-two people in four states with two hospitalizations; Minnesota and Oregon are new, and ten people have been added. The recalled sprouts carried use-by dates of September 7 through 16, the last of which passed eight days ago, and CDC still lists the investigation as open. Ten more people and two more states, and the two are Minnesota and Oregon CDC’s September 24 investigation update moved the last illness onset from August 26 to September 3. Of the twenty-seven people interviewed, twenty-six reported eating sprouts or microgreens, twenty-two named broccoli sprouts, and one reported a microgreen mix containing broccoli microgreens, against a FoodNet baseline of 8.7 percent for eating any sprouts in the prior week. Three of the thirty-two have been hospitalized, 9 percent. CDC’s map shows where sick people live, not where they bought sprouts. Confirmed distribution is still Idaho, Montana and Washington, and both the recall notice and FDA’s advisory say product may have gone further. Utah has had a case since September 9 without appearing on the distribution list, and Minnesota and Oregon now join it. The microgreen line is new too: CDC does not say who grew that mix, the recall covers broccoli sprouts only, and FDA says its investigation is ongoing to determine the source of contamination and whether additional products are affected. That is the sentence to watch. Twenty-five of the thirty-two got sick before the first recalled bag was delivered CDC’s onset data, exported September 22 and posted with today’s update, shows two waves. Four people got sick in the second week of July, no one for the next nineteen days, and then twenty-seven between August 2 and August 28, with the busiest single day August 19, when five people fell ill. One more began September 3. | Week beginning | Onsets | | ------------------ | ---------- | | July 5 | 2 | | July 12 | 2 | | July 19 | 0 | | July 26 | 0 | | August 2 | 4 | | August 9 | 6 | | August 16 | 9 | | August 23 | 8 | | August 30 | 1 | | Total | 32 | Illness onsets by week, Sunday through Saturday, computed from the CDC data export dated September 22, 2026 and posted with the September 24 update. The nine weeks sum to thirty-two. Now put the recall against that curve. The company’s notice says the recalled bags were delivered to distributors between August 24 and September 2. Twenty-five of the thirty-two people were already sick by August 23, and Salmonella takes six hours to six days to make someone ill, so none of those twenty-five could have eaten a recalled bag. By its own dates the recall could account for at most the last seven illnesses. The other twenty-five ate broccoli sprouts from earlier production that was never recalled, because it had been eaten or had expired before anyone knew. That is the ordinary arithmetic of a sprout recall, and it is also why the count keeps rising after the product is gone: CDC says it usually takes three to four weeks to confirm that a sick person belongs to an outbreak, the newest onset is exactly three weeks old today, and bags with September 14 and 16 use-by dates were still on shelves after it. Washington holds twenty-four of the thirty-two, and its own page still says twenty-one The Washington State Department of Health last updated its page on September 17: twenty-one Washington residents in nine counties, two hospitalized, and two more broccoli sprout samples positive for the outbreak strain, one from a sick person’s home and one from a local food co-op. CDC’s map now carries twenty-four Washington residents, three the state page does not yet show. Montana’s page has not moved since September 3, when it reported two Montana residents and said local sanitarians were contacting stores one at a time to pull the sprouts; CDC has Montana at four. The state pages and CDC’s page are updated on different days by different people. Use the number attached to whichever agency you cite, and do not add state totals on top of CDC’s national count. | County | Cases | | ----------- | --------- | | Clark | 2 | | Island | 1 | | King | 5 | | Skagit | 2 | | Snohomish | 1 | | Spokane | 3 | | Walla Walla | 1 | | Whatcom | 5 | | Yakima | 1 | | Total | 21 | Washington cases by county of residence, as reported by the Washington State Department of Health on September 17, 2026. The nine counties sum to twenty-one. Four positive sprout samples, 1,290 bags and one week of use-by dates The recall Evergreen initiated on September 4 reached FDA’s recall page on September 10. It covers 215 cases of six four-ounce bags, 1,290 bags in all, UPC 8 38796 00105 1, with use-by dates of September 7, 9, 11, 14 and 16, delivered to three Washington distributors between August 24 and September 2 and sold on to stores in Idaho, Montana and Washington. The company says it stopped producing and shipping broccoli sprouts on September 4, that a third-party laboratory found Salmonella in a bag with a September 16 use-by date, and that a root cause investigation is under way. The laboratory record is unusually strong for a sprout outbreak. Montana officials collected an unopened package from a sick person’s home, and whole genome sequencing matched it to the outbreak strain. Washington’s two samples, from the co-op and the sick person’s home, matched as well. Add the company’s own positive and there are four positive product samples. In Evergreen’s 2011 and 2014 outbreaks the product samples never matched, and epidemiology and traceback carried those investigations alone, as I wrote when FDA and CDC posted their pages on September 9. One gap in the notice remains: the company’s announcement describes bags, while CDC and Washington describe bags and clamshell containers sold through grocery stores, food co-ops and restaurants. Evergreen’s third outbreak since 2011, and the running total is now seventy-six In 2011, twenty-five people in five states were infected with Salmonella Enteritidis from alfalfa and spicy sprouts sold under the Evergreen Produce label. The company declined FDA’s request to recall until FDA warned the public directly, then recalled on July 1. In 2014, nineteen people in six states were infected with E. coli O121 traced to Evergreen’s raw clover sprouts, and there was no recall at all. Twenty-five plus nineteen plus thirty-two is seventy-six people over fifteen years from one grower. The history, with sources, is in my September 3 post. Not the alfalfa outbreak, and not the only sprout recall this month CDC says this outbreak does not appear to be related to the Salmonella and E. coli outbreak traced to alfalfa sprouts from Everything Sprouts of Minneapolis, which stands at fifty-five sick in fifteen states on FDA’s advisory. A Minnesota resident on today’s map is a state of residence, not a second link between the two: the serotypes are different, the growers are different, and the seed lots are different. That outbreak has produced its own chain of recalls, from the grower to the seed supplier to two retail seed sellers, and Evergreen’s is one of six sprout or sprouting-seed recalls posted between August 22 and September 23. FDA has told the public not to eat raw sprouts since 1999. The bag still does not say so. On July 9, 1999, FDA advised that anyone who wants to reduce the risk of foodborne illness should not eat raw sprouts, and that children, the elderly and people with weakened immune systems should not eat them at all. Twenty-seven years later that advice is on FDA’s website and nowhere on the package. I first asked FDA to require a warning statement on raw sprouts in March 2003, during a Salmonella outbreak traced to sprouts in Oregon, Washington and California. Two sprout outbreaks, eighty-seven sick people and six recalls in one summer are the argument, again. What to do Do not eat Evergreen Fresh Sprouts broccoli sprouts with use-by dates of September 7 through 16. Throw them away or return them, and wash anything they touched with hot soapy water or in a dishwasher. Restaurants and retailers should not sell or serve them. Symptoms of Salmonella usually begin six hours to six days after exposure, and most people recover in four to seven days. Call a doctor for diarrhea with a fever above 102°F, diarrhea lasting more than two days, bloody diarrhea, vomiting so severe that liquids will not stay down, or signs of dehydration. If you ate these sprouts and became ill, ask to be tested. A confirmed case is what connects a person to the outbreak, and it is where the next update’s numbers come from. Marler Clark’s page on this outbreak is here.
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MINING AND MINERAL RESOURCES

FDA Won a Consent Decree Against a Minneapolis Warehouse That Kept Infant Formula, Rice and Cat Food Among 26 Rodents and Nine Birds. The State Had Inspected It 26 Times Since 2013. No One Has Been Charged.

A federal judge in Minnesota entered a consent decree on September 21, 2026 that bars Gold Star Distribution, Inc. and its owner, Bassam Abu Samrah, from receiving, holding or shipping any FDA-regulated product until FDA says in writing that the North Minneapolis warehouse is fit to use. FDA announced it September 23. Investigators who walked the building from November 17 to December 18, 2025 counted nine live rodents, seventeen dead ones, eight live birds, one dead bird and five live worms among rice, cat food, over-the-counter drugs and, according to the government’s complaint, Enfamil infant formula. No illnesses have been reported. The story is not the rodents. The story is the calendar. Inspectors found rodents, birds and worms in a warehouse that supplied WIC stores with infant formula. FDA’s release is specific. Inspectors documented rodent excreta pellets, urine stains and gnaw holes in product packaging, refuse leaking near outgoing shipments, and ceiling leaks over stored goods. The agency’s laboratory confirmed rodent urine, excreta and hairs on packaging and gnaw holes through it. The complaint filed September 11 in the District of Minnesota, as reported by Hoodline and Medical Daily, names the stock: Enfamil and Enfamil Gentlease infant formulas, Meow Mix and Friskies, Tylenol, Advil and DayQuil, basmati rice, pregnancy tests and sanitary pads. The Minnesota Department of Health’s WIC program told its local agencies on January 6, 2026 that Gold Star “supplies food and infant formula products to some small WIC-authorized stores in Minnesota,” and that WIC could not reissue the recalled items on a participant’s card. The families who buy formula at a corner market on a WIC card are not the families with a second option. The state had been in the building 26 times since 2013, and FDA five times before 2025. That is FDA’s own count. The Minnesota Department of Agriculture inspected Gold Star 26 times between 2013 and 2025. FDA inspected it five times before the 2025 inspection that produced the complaint. Earlier visits, the release says, “documented rodents, gnaw marks, excrement, and nesting materials.” According to the complaint as reported, the state issued three warning letters between 2018 and 2025, imposed two monetary penalties and put the firm under a two-year license limitation agreement. None of it changed the building. The Department of Agriculture, the Board of Pharmacy and FDA all knew the address. The table below is the whole record as the government has now told it. | When | Who | What happened | | --------------------- | ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- | | 2013–2025 | Minnesota Department of Agriculture | 26 inspections of the Humboldt Avenue warehouse | | Before 2025 | FDA | 5 inspections documenting rodents, gnaw marks, excrement and nesting material | | 2018–2025 | Minnesota Department of Agriculture | 3 warning letters, 2 monetary penalties, a 2-year license limitation agreement (per the complaint) | | Nov. 17–Dec. 18, 2025 | FDA | 9 live and 17 dead rodents, 8 live birds, 1 dead bird, 5 live worms; lab confirms rodent urine, excreta, hair and gnaw holes on packaging | | Nov.–Dec. 2025 | MDA and Board of Pharmacy | 2 embargo and cease-and-desist orders; food wholesale license revoked; pharmacy cease-and-desist for unlicensed OTC drug distribution | | Dec. 26, 2025 | Gold Star Distribution | Voluntary recall of every FDA-regulated product it held, shipped to 59 stores in Minnesota, Indiana and North Dakota | | Sept. 11, 2026 | United States | Complaint for injunction filed, D. Minn. No. 0:26-cv-03976 | | Sept. 21, 2026 | Judge Laura M. Provinzino | Consent decree of permanent injunction entered | | Sept. 23, 2026 | FDA | Press release | Table: Government contact with Gold Star Distribution, 2013–2026, compiled September 24, 2026 from FDA’s September 23 press release, the December 26, 2025 recall notice, the Justia docket and press reports of the complaint. Check: 26 state inspections plus 5 FDA inspections equals 31 before the November 2025 inspection; 31 plus 1 equals 32 in all, over roughly thirteen years. The December recall pulled nearly 2,000 products from 59 stores, most of them small markets and delis. Gold Star’s December 26, 2025 recall notice covered everything FDA regulates that passed through the warehouse between August 1 and November 24, 2025: human food, pet food, dietary supplements, drugs, medical devices and cosmetics, shipped to 59 retail locations, most of them specialty markets and delis, and running to nearly 2,000 products by CBS Minnesota’s count. The notice carries the standard warning that Salmonella “can cause serious and potentially fatal infections in infants, young children, elderly people, pregnant people and people with weakened immune systems.” Rodent excreta is how Salmonella gets onto a package. Consumers were told to destroy the products and send proof of destruction for a refund. No illnesses have been reported, and nothing in the record suggests anyone could have found the customers who bought over the counter at 59 small stores. The decree tells Gold Star to stop, clean up and prove it. It does not punish anyone. The consent decree does what a civil injunction under 21 U.S.C. § 332 does. Gold Star must stop receiving, holding and distributing FDA-regulated products; hire an independent expert to write sanitation and drug-storage plans; eliminate the pests and the filth; renovate the building; destroy every FDA-regulated product on hand under FDA supervision; pass inspections by the expert, a pest-control company and FDA; and wait for written notice from FDA before reopening. Elizabeth Miller, FDA’s Associate Commissioner for Inspections and Investigations, said: “When a company repeatedly ignores serious, ongoing violations that put trust at risk, the FDA will act.” She is right that FDA acted. The question a parent in North Minneapolis is entitled to ask is why acting took from 2013 to 2026, and why the answer, after 32 inspections, is a promise to clean up. Family Dollar’s rat warehouse drew a $41.675 million guilty plea. This one drew an injunction. In June 2024 Family Dollar pleaded guilty to holding food, drugs, devices and cosmetics under insanitary conditions at its West Memphis, Arkansas distribution center, and paid $41.675 million, the largest criminal penalty ever in a food safety case. The conduct was the same conduct: live rodents, feces, urine and nesting in a building that shipped to stores. The difference was the charging decision. Family Dollar is a national chain with a legal department; Gold Star is one man and a warehouse on Humboldt Avenue. I do not argue that every rodent case is a criminal case. I argue that a thirteen-year record of state and federal findings, three warning letters, two penalties, a revoked license and infant formula on the shelves is the record a prosecutor looks at, and that in August I counted eighteen federal food crime prosecutions in forty years. Executive Order 14294 now steers agencies away from regulatory crimes. Gold Star is what that policy looks like on the ground. Deterrence is a line item until someone is charged. I wrote on Monday, in a note to Tom Gremillion, that a civil check is a line item and a criminal charge is personal. Gold Star’s decree carries no check at all. It carries a to-do list. The owner keeps the building, keeps the business and can reopen when FDA signs off. Every other warehouse operator in the Upper Midwest who read FDA’s release on Wednesday learned the same lesson: twenty-six state inspections and five federal ones buy you a consent decree and a press quote. On Sunday I wrote that Abbott paid $385 million and nobody was charged. Gold Star paid nothing and nobody was charged. The two cases sit at opposite ends of the industry and reach the same place. Three things would have changed this record, and none of them is new. First, an inspection history that follows a firm. A state inspector on visit twenty walks in with visits one through nineteen on a screen, and the federal complaint is drafted at visit ten, not thirty-two. Second, a charging guideline. I asked Attorney General Blanche in August to publish one and to say whether the strict-liability misdemeanor under the Food, Drug, and Cosmetic Act is still a charge the Department will bring. A published rule that repeated insanitary-holding findings after a warning letter will be referred for prosecution would have reached Humboldt Avenue years before a consent decree did. Third, a way to find the customers. The recall went to 59 stores; the people who bought infant formula there were never identified, so no one knows whether anyone got sick. The government did its job in the end, and the people who did it deserve credit for a thorough inspection and a decree with teeth on the cleanup. The architecture around them let a building with rodents in it hold baby formula for thirteen years. That is the part worth stopping on.
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AGRICULTURE AND FOOD PRODUCTION

The Seed Lot Behind the Alfalfa Sprout Outbreak Was Sold at Retail in 44 States, and the Small Bags Carry No Lot Code. It Is the Sixth Sprout Recall in a Month, and FDA’s Advisory Still Names No Supplier. And FDA’s Table Added 65 Sick People with No Food Named: 25 With E. coli O157:H7 and 40 With Listeria.

Berlin Seeds of Millersburg, Ohio, recalled 950 pounds of alfalfa sprouting seed on Wednesday, and FDA posted the notice the same day. The seed is from lot SAL2-24JB, the lot International Sprout Holdings of Cookeville, Tennessee, began recalling on August 23 after alfalfa sprouts grown from it by Everything Sprouts of Minneapolis were tied to 55 illnesses in 15 states: 46 with Shiga toxin-producing E. coli of three serotypes, seven with Salmonella Agona, two with both, four hospitalized. Berlin Seeds sold the seed from February 13 to August 23, in its store and online, to customers in 44 states, in bags from a quarter pound to 50 pounds. Only the five- and 50-pound bags bear the lot code. One illness has been reported to the company. It is the sixth recall of sprouts or sprouting seed since August 22. The same day, FDA’s outbreak table added two investigations with no food named, 25 people sick with E. coliO157:H7 in a joint file with USDA and 40 sick with Listeria monocytogenes, moved the Salmonella Newport file to 116, marked every remaining Cyclospora file ended, and closed the frozen blueberry and moringa files. Ten rows on the table now name no food. They carry 645 people. The seed lot is a retail product now, and a quarter-pound bag has nothing on it to check On September 15 FDA’s advisory said the recalled seed lot went to sprout growers and wholesale distributors and may also have reached retail. Berlin Seeds sold it in five sizes, from a quarter-pound resealable bag to a 50-pound sack, in every state but six. The lot code is printed only on the five- and 50-pound packages. For the smaller sizes, the purchase window is the only identifier. The notice says the supplier told Berlin Seeds the lot had been traced to a sprout grower in FDA’s investigation, and that spent irrigation water from one of the supplier’s alfalfa seed lots tested positive for E. coli, the finding Todd’s Seeds cited in its September 15 notice, which named the supplier as International Specialty Supply. Berlin Seeds’ notice does not name the supplier, as Food Safety News noted. The 950 pounds is about two percent of the 43,799-pound lot. The illness reported to Berlin Seeds is a report, not a confirmed case; nothing public says whether that person is among the 55. The dates say this seed was in home kitchens long before anyone got sick: Todd’s Seeds shipped its lots beginning January 10, Berlin Seeds began selling February 13, and the first outbreak onset was May 31. Sprouting seed means days in warm water, the conditions that grew four pathogens out of this lot in Minneapolis. Three recalls of one lot in a month, and the page the public reads names none of them | Date | What happened | Where it is on the record | | -------- | ------------------------------------------------------------------------------------------------------------------- | ------------------------------------------- | | Aug. 22 | Everything Sprouts recalls Calco and Everything Sprouts alfalfa sprouts | FDA recall page; advisory updated Aug. 24 | | Aug. 23 | International Sprout Holdings begins recalling lot SAL2-24JB by email to customers; Berlin Seeds’ sales window ends | FDA Enforcement Report; Berlin Seeds notice | | Aug. 31 | FDA says the supplier has not responded to its recall recommendation, and a second grower used the lot | FDA advisory | | Sept. 10 | The supplier’s recall appears in FDA’s weekly Enforcement Report | Enforcement Report; eFoodAlert | | Sept. 15 | FDA says the supplier agreed to recall, and the lot may have reached retail; Todd’s Seeds posts its notice | FDA advisory; Todd’s Seeds website | | Sept. 23 | Berlin Seeds’ notice is posted | FDA recall page | FDA’s advisory is still stamped September 15. It names no supplier, no lot number, no second grower and no retailer. Its distribution list, 16 states plus Puerto Rico, Canada, Mexico, Tahiti and Venezuela, is the wholesale tier. Berlin Seeds’ 44 states are the retail tier for two percent of the lot, and that notice sits on FDA’s recall page, not on the outbreak page a home sprouter would read. The supplier’s name has been public since Phyllis Entis found it in the Enforcement Report on September 10, and I wrote about it that day; the advisory still omits it. Berlin Seeds says the recall was initiated after the supplier notified it and does not say when. The record shows sales stopping on August 23, the day the Enforcement Report says the supplier began emailing customers, and a public notice on September 23. What happened to the retail notice in those 31 days is a fair question for FDA and both companies, and no page answers it. Sprouts again: two outbreaks this summer, five sprout files on FDA’s tables in two years, six recalls in a month This recall does not stand alone. Evergreen Fresh Sprouts of Moyie Springs, Idaho, recalled its broccoli sprouts September 4 after a Montana sample matched the outbreak strain; CDC counts 22 sick with SalmonellaBovismorbificans in Idaho, Montana, Utah and Washington, two hospitalized, and Washington’s own countreached 27 on September 17. That is FDA reference #1411, posted September 10, and CDC says the two sprout outbreaks do not appear to be related. It is Evergreen’s third outbreak since 2011, after Salmonella Enteritidis in 2011 and E. coli O121 in 2014. Behind those two sit three more sprout files on FDA’s closed tables. Salmonella Oranienburg in alfalfa sproutsfrom an unnamed Arizona grower, five sick, closed in 2025 with FDA’s own summary saying the source was likely the seed. Salmonella Anatum in Deep-brand frozen sprouted beans, 12 sick in 11 states, four hospitalized, recalled in July 2025. And E. coli O26:H11 in sprouts, ten sick, posted October 2024 and closed with no firm named. Counting the Everything Sprouts recall and its expansion, the supplier’s seed recall, Evergreen, Todd’s Seeds and Berlin Seeds, that is six recalls of sprouts or sprouting seed in 32 days. FDA’s own guidance for seed producers says contaminated seed has been the most common source of sprout contamination and the likely cause of most sprout outbreaks from 2012 to 2020, which is why I am drafting a citizen petition asking FDA to require a warning statement on the package, the advice it has given high-risk consumers since 1998. Two new outbreaks, 65 sick, no food named, and one of them has a USDA number Reference #1421 is E. coli O157:H7, 25 sick, posted September 23 with traceback initiated, the only active row with a USDA number, FSIS reference 2026-04. FSIS’s outbreak page explains the shared number: an outbreak appears on both tables when products regulated by both agencies are suspected sources. In plain terms, meat or poultry has not been ruled out. The last two rows on FDA’s table with USDA numbers were Listeriaoutbreaks in prepared pasta meals and ready-to-eat deli foods, multi-ingredient products. When I wrote about FSIS’s table in August, it listed three investigations for all of 2026, everyone closed. This would be the fourth. Reference #1417 is Listeria monocytogenes, 40 sick, traceback initiated, with no states, ages, hospitalizations, deaths or onset dates. For a pathogen CDC estimate sickens about 1,600 people a year and kills about 260, and which hospitalizes nearly everyone counted in an outbreak, 40 is a large file; the 2024 Boar’s Head outbreak, which my firm litigated, ended at 61 sick and ten dead. Such clusters can include illnesses years apart, and without dates the row does not say. Neither file has an advisory, and as of this writing CDC had posted no notice for either. Ten rows with no food named now carry 645 people The table lists 16 active investigations. Ten name no food: the new O157 and Listeria files at 25 and 40, Salmonella Newport at 116, Salmonella I 4,[5],12:i:- at 43, Salmonella Oranienburg at 99, the older Listeriafile at ten, and four Cyclospora files at 234, 38, 22 and 18. That is 645 people. A week ago, eight rows carried 575. The Newport file, posted August 26, went from 111 to 116 and, for the first time, shows sampling initiated: four weeks of traceback have produced something to sample, and the table does not say what. All five Cyclosporafiles are now marked ended while FDA’s investigations stay active; the four with no food named hold 312 people, part of the 7,000 confirmed cases no outbreak file explains. Two files moved to the closed table. The frozen blueberry E. coli O145:H28 file closed at 17 sick and six hospitalized in Florida and Georgia; CDC ended it September 21, and FDA’s final update disclosed that a sample Publix collected early on matched the outbreak strain, the first strain match to product on the advisory. The moringa leaf powder file, 131 sick, 36 hospitalized, 38 states, posted January 14, also closed. FDA’s advisory said the investigation was complete on July 22; the table carried it as active for two more months. My firm represents people sickened in the moringa outbreaks. Three questions Which Berlin Seeds bags are recalled? Every size sold from February 13 to August 23, 2026. Lot code SAL2-24JB is printed only on the five- and 50-pound bags; the smaller bags carry no code. Is this the seed that caused the alfalfa sprout outbreak? It is the lot number in the supplier’s recall in FDA’s Enforcement Report, and Berlin Seeds says the supplier traced the lot to a grower in FDA’s investigation. FDA’s advisory has not been updated to say so. Is this related to the broccoli sprout outbreak? No. CDC says the Everything Sprouts and Evergreen Fresh Sprouts outbreaks do not appear to be related. The seed lot is the common thread in this outbreak, and sprouts are the common thread in the season. The public list of where the lot went is being assembled one retailer notice at a time, a month after the supplier started emailing, on a page most people never open, while the advisory they do open names nobody. And the table added 65 people and no food on the same day it closed two files whose most useful facts reached the page only at the end.
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