To Recall or Not to Recall?

These past few months have brought to light the significance of how food recalls work in practice and the regulatory vs. voluntary nature of them. As consumers pay increasing attention to their food products, recalls — and how they’re handled — also are being closely monitored.

In mid-March, the U.S. Food and Drug Association (FDA) linked a multistate outbreak of E. coli O157:H7 infections to Raw Farm-brand raw cheddar cheese. FDA then recommended the country’s largest raw milk producer, based in Fresno, Calif., recall the products that included multiple sizes of original and jalapeño raw cheddar cheeses. Raw Farm declined.

What followed was a series of requests from FDA for the company to recall those products as illnesses linked to the outbreak increased, with more than half of cases occurring in children under 5. The Congressional Food Safety Caucus pressed FDA to force a recall.

On April 2, more than two weeks after FDA’s initial recommendation, Raw Farm issued a voluntary recall “under protest,” citing the action “as a path forward” but disputing the legitimacy of FDA’s evidence. On April 7, Raw Farm withdrew those statements while still contesting the agency’s findings.

In its investigation, FDA reported that a sample of Raw Farm’s raw cheddar cheese tested positive for E. coli O157:H7 on April 16. With further testing using whole genome sequencing, the analysis revealed that the strain matched illnesses from a separate 2025 outbreak investigated by the Centers for Disease Control and Prevention (CDC). CDC announced that the outbreak was over on April 30 and that ill people from the 2025 outbreak did not report consuming Raw Farm products.

The outbreak, with onset dates ranging from Sept. 1, 2025, to Feb. 20, 2026, sickened nine people and hospitalized three across California, Florida and Texas, FDA reported. One person developed hemolytic uremic syndrome (HUS), a serious condition that can cause kidney failure. No deaths were reported.

Bill Marler, managing partner, Marler Clark, a law firm specializing in food safety litigation, said there are times when outbreaks are linked epidemiologically to a product, but, when initially investigated at the company’s farm or facility, samples aren’t immediately linked to the outbreak.

“The farm and the farmer or somebody [then] says, ‘Well, that just shows you it wasn’t us,’” Marler said. “Because (a) they want to believe it wasn’t them, but (b) they also don’t want to believe in the science of epidemiology.”

Cooperation vs. forced compliance.

Food recalls are often described as voluntary. Companies approached by government agencies with evidence that their products are likely causing illness or are contaminated typically issue a recall on their own, Marler said.

But what happens if a company refuses to recall? Marler has rarely seen FDA force a recall, but it can happen. 

If a company declines to voluntarily recall its product, a government agency can act in a couple of ways, Marler said. The agency, such as FDA, can issue an alert to the public about the product. The agency can also go to a court and ask a judge to order a recall. The court, Marler said, will always defer to FDA and force the recall.

Bill Marler

“The other thing is that if, in fact, they don’t recall the product and somebody buys the product off the grocery store shelf … and eats it and gets sick and dies, not only is a person entitled to compensatory damages for their illness and death, but they could also be entitled to punitive damages,” said Marler.

It’s also uncommon for public health agencies to incorrectly identify the source of an outbreak, Marler said. He could think of just one instance in his more than 30-year career where an agency got it wrong.

In 2008, a Salmonella Saintpaul outbreak sickened more than 1,400 people across 43 states from April to August of that year. Initially, FDA linked the source of the outbreak to tomatoes, issuing a nationwide warning to the public on June 7, 2008, to avoid eating raw red round, red Roma and red plum tomatoes, CDC reported. The agency lifted its warning on July 17. It was determined that contaminated jalapeño and serrano peppers from Mexico were the primary source of the outbreak.

Members of the tomato industry later sued FDA for compensation for monetary losses they experienced during the outbreak, but the judge sided with the agency.

“The court said, ‘Hey, the FDA and CDC, their job is to try to protect the public, and at the time, the facts were reasonably known, and it certainly looked like tomatoes,’” Marler said.

Communicating recalls.

Rutgers University researched public perception of the 2008 tomato advisory, determining the specifics of the outbreak weren’t well understood and that people were left confused about what produce was safe to eat.

More recently, a 2026 report titled “Food for Thought” by the U.S. Public Interest Research Group (PIRG) Education Fund said that the U.S. food recall system doesn’t “instill confidence in food safety.” The report cites lagged recall announcements, a lack of public recall announcements and limited details about investigations as its concerns about how food recalls are handled from a regulatory standpoint.

In part of the report’s executive summary, PIRG questioned why the June 2025 recall of FreshRealm ready-to-eat pastas due to possible Listeria contamination took nearly a year to achieve, as the outbreak strain was linked to illnesses ranging from August 2024 to May 2025. In September 2025, additional pasta recalls were announced that were related to the June recall. As of October 2025, FDA reported that 25 people were hospitalized and six people had died from the outbreak. PIRG questioned if lives could have been saved if more information about the contaminated products were available sooner.

How FDA manages recalls.

When FDA determines a company’s product may be linked to an outbreak, it reaches out to the firm to discuss potential actions they can take to protect public health, FDA said in an emailed statement to QA. FDA-regulated companies can initiate their own recall at any time. The agency said voluntary recalls are the most efficient avenue in removing products from the market, and companies typically do cooperate.

If a company decides under any circumstance to voluntarily recall a product, it is considered a “firm-initiated recall,” the agency said. If a company declines to recall, FDA said it “considers all legal and regulatory actions available.” One of these actions is the FDA’s mandatory food recall authority, which went into effect when the Food Safety Modernization Act (FSMA) was enacted in 2011.

Section 423 of the Federal Food, Drug, and Cosmetic (FD&C) Act was added by FSMA and gives FDA authority to order a company to recall a food product if it finds the product (other than infant formula), under reasonable probability, to be unsafe or mislabeled or that consumption “will cause serious adverse health consequences or death to humans or animals,” the agency said.

 When the agency determines it has met its requirements to mandate a recall, FDA first must allow the company to voluntarily recall the food product and cease distribution, notifying the company quickly. If the company still refuses to recall, FDA can order the recall and prohibit further product distribution. The agency also said it would allow the company to request an informal hearing that would be held no later than two days after the order. Only the agency’s commissioner can order a recall.

“Taking decisive action early demonstrates a commitment to public health, strengthens trust with customers and regulators and often results in a more focused and manageable response,” FDA said.

Food research’s crucial role.

Advances in food safety research, especially microbial research, continue to provide industry with processing approaches that help keep their products and consumers safe and help industry understand what an effective food recall looks like.

Kathy Glass, Ph.D., worked at the University of Wisconsin-Madison’s Food Research Institute for almost four decades and retired last year, having served as associate director since 2008. She collaborated with the food industry to develop formulation-safe products and improve the microbial safety of low-acid refrigerated foods, ready-to-eat meats and processed cheese.

Glass, who is still active in food safety and was the 2005-2006 president of the International Association for Food Protection (IAFP), said current food processing trends focusing on simpler ingredient labels and the removal of effective preservatives can unintentionally create food safety problems. She added that while suppliers have developed novel food protection strategies, such as cultured products with antimicrobial activity, the ingredients remain proprietary and differ from other suppliers’ products with similar names.

“As academics, we try to get back down to the effectiveness of the basic compounds in these ingredients and the control measures that go along with them, all while working closely with the industry,” Glass said. “What we learn from one project, we can often apply to another. As academics, we share food safety information. It’s not a secret. When we have recalls like the E. coli in raw milk cheese, we just look at it and shake our heads. … At this stage of the game, you should’ve known better what the risks are.”

From mild symptoms to life-threatening illness, different foodborne pathogens carry different levels of risks, Glass said, but delaying a recall always carries great risk, especially for more vulnerable populations such as the elderly, children, pregnant people, those with chronic illness, and others.

“Any delay in responding to a contamination issue increases the likelihood that more consumers will become ill and even suffer worse consequences,” she said.

A collaborative future.

Although Glass said consumers may think they see more recalls being issued now than ever, the reality is that industry is getting better at detection. She explained that recalls may seem bigger because of the consolidation of the food supply.

Recall management will soon receive another layer of support with the FSMA Section 204 Food Traceability Final Rule, which will require companies that manufacture, process, pack or hold “high-risk” foods on FDA’s Food Traceability List to meet its record-keeping requirements, allowing for faster identification and removal of contaminated products. FDA extended the compliance deadline for the Food Traceability Final Rule, originally set for Jan. 20, 2026, to July 20, 2028.

Roger Hancock, CEO, Recall InfoLink, a software company that helps businesses manage recalls, has observed how companies are adapting to the Food Traceability Final Rule. Accomplishing successful traceability implementation requires data compatibility and collaboration across the supply chain, he said.

“Traceability isn’t an individual company concept. It’s a supply chain concept,” Hancock said. “The best way to implement something at your company that works for your supply chain is to do it in collaboration with your supply chain.”

Companies’ traceability data also must be compatible with their partners’ systems, Hancock said, or else programs can’t ingest the data coming from different areas of the supply chain. Having a data standard will simplify compatibility work between trading partners, he said. When recalls happen, all sectors need to understand the data and what to share — and be able to act on it.

“There’s different data sets that come together to make a recall. One of them is traceability data,” Hancock said. “The faster you can get that traceability data, the faster you can protect your customer, faster you can protect your brand, faster you can protect your business.”

Business, academia, technology, law and government — along with others — are all distinct sectors that make up the food industry. When food recalls occur, collaboration is required, but sometimes a party may refuse or delay action, potentially risking consumers’ health and leaving the ultimate authority to regulatory bodies to decide what to do.

“The one takeaway [from the Raw Farm case], candidly, is that [a company] could tell the FDA to back off, and they won’t do anything,” Marler said. “I don’t think that’s the right way to approach it, but to be candid, if the FDA is not going to use its power that it’s got in a situation where the product is known to have caused illness, why would not the next company take the same position? That’s a risk that I don’t think any of us in the food safety space think is a good idea.”