FDA classifies recall of Sierra Nevada raw-milk cheese as highest risk amid E. coli outbreak

The Food and Drug Administration has classified a nationwide raw-milk cheese recall as Class I, its most serious risk category, in an update reported this week that comes nearly a month after a Northern California creamery pulled its entire product line over a multistate E. coli outbreak. The recall covers every Graziers-brand raw milk cheese made by Sierra Nevada Cheese Company of Willows, California, and a Class I designation means the agency has determined there is a reasonable probability that eating the product could cause serious injury or death.

The classification does not reflect a new recall. It is the FDA's formal conclusion to a risk review that began when the company first pulled its cheeses in late September, and it was reported by Newsweek and a Gray Television affiliate this past Monday. The underlying outbreak investigation, run jointly by the FDA and the Centers for Disease Control and Prevention, remains open.

The numbers behind the recall

According to the FDA's outbreak investigation page, 13 illnesses tied to the strain E. coli O26:H11 have been confirmed across nine states: California, Colorado, Georgia, Kentucky, Michigan, Nevada, Oregon, Tennessee and Utah. Eight of those thirteen people were hospitalized, and three developed hemolytic uremic syndrome, a form of kidney failure that is among the more severe complications of infection with Shiga toxin-producing E. coli. No deaths have been reported. Patients ranged in age from 1 to 58, with a median age of 5, and health officials say more than half of those sickened were children five years old or younger — the group most susceptible to kidney complications from this type of infection. Illness onset dates span from early July through August 26.

Investigators interviewed nine of the thirteen confirmed patients about what they had eaten in the week before falling ill; all nine reported having consumed Graziers raw milk cheese, a pattern the FDA's outbreak page describes as "epidemiologically associated" with the medium cheddar variety specifically, though the agency has not pinpointed a single contaminated lot or production run.

Why the recall covers the company's full product line

Sierra Nevada Cheese Company makes its Graziers line from unpasteurized, or "raw," milk, a process that some artisanal producers favor for flavor but that federal food-safety guidance treats as inherently riskier than pasteurized dairy, since the heat treatment that kills harmful bacteria is skipped. Because investigators had not been able to trace the contamination to a specific date code, the company recalled every unit of Monterey Jack, jalapeño jack, medium cheddar and sharp cheddar in the market "out of an abundance of caution," according to its FDA-published recall notice — not a narrower batch, as is more typical when a source lot is known.

A detailed accounting of lot numbers and expiration dates later published to the FDA's enforcement database and summarized by the food-safety trade outlet Food Poisoning Bulletin runs to well over a hundred separate lots spanning production dates across more than a year, underscoring how broadly the recall reaches into the company's inventory. The affected cheeses were sold in 8-ounce squares and bricks, 16-ounce bricks, 5-pound loaves for food-service buyers, and 40-pound blocks for wholesale distribution.

"At this time, the investigation has not been narrowed to a specific lot, date code, or production date. Therefore, out of an abundance of caution, Sierra Nevada Cheese Company is recalling all the Graziers Raw Milk Cheese products listed below currently in distribution."

Who bought the cheese

Graziers products reached stores nationwide, with retail and food-service distribution confirmed in at least thirteen states — Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, New Jersey, Oregon, Texas, Washington and Wisconsin — in addition to export shipments to South Korea noted on the FDA's outbreak page. The products were sold both as packaged retail cheese and in bulk to restaurants, delis and wholesalers, meaning consumers may have eaten the cheese without necessarily buying it themselves, for instance in a sandwich or cheese board prepared by a third party.

The FDA is telling consumers not to eat, sell or serve any of the recalled cheeses, to check refrigerators and freezers for products that may have been repackaged without clear labeling, and to throw away or return anything that cannot be positively identified as outside the recall. Because the cheeses have a long shelf life, some product may still be sitting in home refrigerators weeks after it was purchased. The agency also recommends cleaning and sanitizing any surfaces, knives or containers that touched the cheese, following its general safe food-handling guidance, to avoid cross-contaminating other food.

What happens next

Sierra Nevada Cheese Company says it stopped all production and shipment of Graziers cheese once the FDA contacted it about the outbreak, and it is offering refunds to consumers who return the product, with a dedicated phone line and email address listed in its recall notice for questions. The company has not been named in any litigation tied to the outbreak as of this week, and no additional statement beyond its original recall announcement has been issued publicly.

The FDA and CDC say their investigation remains active, with case counts subject to revision as more illnesses are reported and matched to the outbreak strain through genetic sequencing — a process that can lag behind actual exposure by several weeks, since symptoms of E. coli infection can take up to nine days to appear and reporting to health departments takes longer still. Neither agency has announced a timeline for identifying the specific source of contamination inside the company's production process, and the FDA's own case page is marked simply "ongoing." The Class I classification itself changes little for consumers who have already heard the central warning — do not eat the cheese — but it does put the episode on the agency's public ledger as one of its highest-severity food recalls of the year, a designation reserved for incidents where the health stakes, not just the business disruption, are significant.