The FDA Has Had the Power to Force a Recall Since 2011. It’s Used It Once — And Never for Pet Food.

In 2011, a law called the Food Safety Modernization Act gave the FDA something it had never had before: the legal power to force a company to issue a pet food recall, even over that company’s objections. That was fifteen years ago. In those fifteen years, the FDA has actually used that power to its full extent exactly once — and not for pet food. That single fact is the real story behind the federal lawsuit the Department of Justice just filed against Darwin’s Natural Pet Products, a raw pet food company, and it’s why I think this matters even if you’ve never fed your pet a bite of Darwin’s food. This isn’t really a story about one bad company. It’s a story about what happens when a regulator has the tool to stop harm and, for fifteen years running, chooses almost never to use it.

Darwin’s is simply the clearest, most recent proof of that. The company sold raw pet food contaminated with Salmonella, Listeria, and E. coli for nearly a decade. Its owner, Gary Tashjian, denied, disputed, or ignored the government finding. Pets died. A child ended up hospitalized on dialysis. And through all of it, the FDA never once forced a recall. It asked, Darwin’s refused, and the cycle repeated for years. What follows is the story of the government’s failure to use the power it has, and, using Darwin’s chronology as proof, just how long that failure was allowed to continue.

This story broke thanks to Phyllis Entis’s reporting on eFoodAlert, and everything below draws on it and on the government’s own court filing as a point of departure.

The FDA Can Force a Recall. It Almost Never Has.

Before 2011, the FDA had no legal authority to force any company to recall a dangerous food, including pet food—it could only ask and hope the company agreed. That changed with the Food Safety Modernization Act, which gave the FDA the authority to issue a mandatory recall order if a company refuses to do so voluntarily and there’s a reasonable probability that the food will cause serious harm or death.

In the fifteen years since, the FDA has invoked that power exactly three times: against Kasel Associated Industries in 2013 (Salmonella-contaminated pet treats), against USPlabs in 2013 (a supplement linked to liver failure), and against Triangle Pharmanaturals in 2018 (Salmonella-contaminated kratom). In two of those three cases, the companies backed down and voluntarily recalled their products once the agency began the formal process. Only once, the kratom case, did the FDA actually have to issue a completed, formal mandatory recall order. That’s the entire record. The Pet Food Institute, the industry’s trade group, states plainly on its website that the FDA can mandate a pet food recall under this authority. “This has never occurred.”

Darwin’s is the clearest illustration of what that gap costs. According to the government’s own complaint, the FDA sent Darwin’s two formal Warning Letters (April 2018 and February 2023) and two separate formal recall request letters (October 2023 and October 2024). The second explicitly warned Tashjian: “If you do not voluntarily recall the above-mentioned product, the FDA may take action against you.” Darwin’s didn’t recall. Nothing happened. As the complaint states plainly: “To date, Defendants have not conducted a recall.”

The Question One Food Safety Lawyer Keeps Asking the FDA

Bill Marler is a food safety attorney who represents the family of the child at the center of this case and is the publisher of Food Safety News. He’s asked this exact question in print more than once. In a piece published on Food Safety News, he asked directly why the FDA hadn’t used its mandatory recall authority against Darwin’s, despite Listeria, three separate Salmonella findings, and a hospitalized child, all within less than a year. He’d asked essentially the same question a year earlier, in a separate piece, after Darwin’s refused yet another recall.

His broader argument is the one that matters beyond this case: when the agency declines to force a recall on a company already known to have caused illness, it tells every other company watching that such a refusal carries no real consequences. Why wouldn’t another company take the same position? And if a customer then gets sick or dies from a product the agency knew about and didn’t force off shelves, the company can end up facing liability not just for the illness, but for choosing profit over safety once the risk was already known.

How Rare Is Federal Legal Action Against a Pet Food Company?

The mandatory recall tool is one lever. A federal lawsuit — what actually happened to Darwin’s — is a heavier, rarer one still. Looking back roughly 20 years, federal legal action against a pet food company, meaning a case that actually reached a court or resulted in criminal charges, has happened four times:

• 2009: ChemNutra’s guilty plea over melamine-contaminated wheat gluten, tied to the deadliest pet food recall in U.S. history.
• 2018: Wilbur-Ellis and Diversified Ingredients pay over $7 million combined for knowingly substituting cheaper ingredients (feathers, bone meal) for the poultry meal they claimed to be selling.
• 2022: Bravo Packing, Inc.: the agency’s own first-ever permanent injunction against a pet food manufacturer under the modern preventive-controls framework. I’ve covered Bravo extensively; a few of the worst of those pieces are linked in the sources below, and I’d urge you to read them.
• 2026: Darwin’s — apparently only the second pathogen-contamination injunction under that same framework.

Four cases in twenty years is not aggressive enforcement. It’s the opposite. A separate HHS Inspector General audit, conducted back in 2009 before the FDA even had mandatory recall power, found the agency’s recall oversight inadequate and its lack of authority a real barrier to getting contaminated food off shelves quickly. That audit helped build the case for giving the FDA the very authority it now almost never uses.

Darwin’s Timeline: Ten Years of Warnings and Refusals

Here’s the chronology, laid out plainly, because it’s the clearest answer to the question “How much has to go wrong before the government finally acts?” Each entry is sourced below in the numbered source key. Where the record only confirms that food tested positive, not that a specific animal’s illness was medically confirmed to be caused by it, I’ve said so. That distinction matters, and it’s honest to note that almost none of the animal cases below reach the same evidentiary standard as the human case further down.

• 2011 ^[1]: Washington State Department of Agriculture first inspects the plant (for compliance with mad cow disease handling).
• 2016 ^[1]: A joint FDA/state inspection finds Salmonella in a finished product sample; the lot hadn’t shipped yet.
• October 2017 ^[1]: One customer’s dog gets sick. An FDA inspector collects the leftover (already-opened) food from her home; it tests positive for Salmonella and Listeria. No veterinary record of the dog’s illness is documented in the source.
• 2017 ^[10]: A kitten dies of a systemic Salmonella infection. Whole genome sequencing matches the Salmonella recovered from the kitten’s liver to Salmonella recovered from an unopened package of the Darwin’s food it had eaten — a confirmed genetic link, independently reported.
• Dec. 6–7, 2017, and Jan. 25, 2018 ^{[2, 1]}: FDA and the state conduct an intensive joint inspection of the plant itself, finding multiple violations; two plant samples test positive for Listeria.
• Feb. 2018 ^[3]: FDA recalls several ZooLogics lots for Salmonella and Shiga toxin-producing E. coli (STEC). FDA’s own page states it had investigated six illness/death complaints in animals to that point.
• Nov. 2018 ^[3]: In a separate, broader matter, FDA’s page notes that the Centers for Disease Control and Prevention (CDC) and several state health agencies were investigating a distinct multistate outbreak of multidrug-resistant Salmonella tied to raw chicken products generally, not specific to Darwin’s. The outbreak strain was found in raw chicken and live chickens and also matched two of Darwin’s chicken pet food samples—a genuine strain match between Darwin’s product and that broader supply-chain contamination.
• April 2, 2018, Warning Letter #1 ^[1]: FDA formally cites Salmonella and STEC contamination.
• April 2018, raw consumer complaints on file with FDA ^[12]: In the same window as the Warning Letter, FDA’s own complaint database logs a 5-month-old Maine Coon kitten who nearly died after eating Darwin’s duck cat food — a fever, a lost pound overnight, and 42 straight hours of emergency vet care — and a 12-year-old dog whose owner reported a full year of recurring lethargy and digestive upset that resolved every time Darwin’s was removed from the diet and returned every time it went back in.
• December 2018 ^[1]: Following a report describing a dog’s Salmonella infection, the FDA collected three unopened lots from the owner’s home; all three tested positive. No vet record or genomic sequencing is documented in the source.
• March 2019 ^[4]: FDA issues a public advisory on three specific dog food lots that tested positive for Salmonella.
• July–August 2022 ^{[1, 5]}: Three kittens in one household get sick. FDA collects three unopened lots from the home; two test positive for Salmonella. No vet records are documented. Darwin’s sues the FDA to block a public advisory and loses on August 4; the advisory is posted on August 5. Darwin escalates to a request for a permanent injunction against the FDA itself and loses that too on December 30, 2022.
• Feb. 16, 2023, Warning Letter #2 ^[6]: FDA cites continued Salmonella contamination and the company’s ongoing refusal to register as a food facility.
• September–October 2023 ^[1]: Four cats in one household get sick. An unopened food sample from the home tests positive for Salmonella. No vet records are documented. FDA sends a formal recall request on October 31; Darwin’s doesn’t recall.
• August–September 2024 ^[1]: FDA finds Salmonella in an environmental swab inside the plant itself. Inspectors document aerosolized water blown directly onto exposed, ready-to-eat product on an uncovered packaging line and in an open hopper, as well as an employee handling soiled paper towels, a filler hose, and finished product without changing or cleaning gloves. All six tested finished-product lots came back positive; one also for Listeria. FDA sends a second formal recall request on October 17; Darwin’s still doesn’t recall.
• August 2024 ^[7]: A four-year-old child develops a STEC infection, then hemolytic uremic syndrome, after the family dog, fed only Darwin’s food, falls ill the day before.
• May–June 2025 ^[7]: A third-party, FDA-accredited lab tests the family’s unopened food from their home freezer: Salmonella in two lots, E. coli O157:H7 in a third, genetically matched via whole-genome sequencing to the strain in the child’s own stool. FDA notes it had no independent retail or plant samples available for this specific incident and relied on this private lab’s results.
• August 2025 ^[1]: A dog dies. FDA collects two unopened packages from the home: one tests positive for Listeria alone, and the other for both Listeria and Salmonella. No autopsy or veterinary cause-of-death record is documented in the source.
• September 2025 ^[8]: Two more lots test positive for Listeria and Salmonella.
• 2016–Jan. 2026 (cumulative) ^[1]: FDA logs 49 total pet illness complaints tied to Darwin’s: 34 dogs (5 died), 35 cats (4 died). As detailed above, the large majority of these are food-testing results, not medically confirmed animal illnesses.
• Aug. 7, 2026 ^[9]: The Department of Justice files a six-count civil complaint, finally seeking a permanent injunction.

Two Warning Letters. Two formal recall requests. Darwin filed a lawsuit against the FDA twice and lost both times. Eighteen tests since 2023 alone, twelve of them positive. Nearly a decade end-to-end. That’s what it actually took — and, as the record above shows, the food was repeatedly and verifiably contaminated, even where any single animal’s illness couldn’t be definitively pinned on a specific package.

Darwin’s Owner, Gary Tashjian, In His Own Words

The pattern only becomes clear when you see it end-to-end. Over nearly a decade, in response to one federal finding after another, Tashjian’s public position has barely moved:

• 2018: “We believe the risk to dogs consuming our products is low.”
• 2019: “We dispute both the recent FDA warning and its policy… we do not believe that the facts support a recall of these products, which is why we have refused to do so.”
• Feb. 2024: Told a customer whose pet’s food tested positive for Salmonella that it “is fine.”
• Sept. 2024: “Darwin’s is confident our meals are safe,” calling the Salmonella found “inherent to poultry” and stating third-party testing showed the lots were negative for Listeria, even as the agency’s own testing found otherwise.
• Aug. 2026, responding directly to the government’s complaint: “We strongly disagree with the FDA’s recent claims and intend to vigorously defend our ability to continue making safe, high-quality raw pet food. In the meantime, we remain squarely focused on our top priorities: supporting the health and wellbeing of the pets we serve.”

Nearly every documented instance of contamination over eight years has been met with denial or dispute by Tashjian personally, rather than correction. It isn’t “the company” that refused these recalls in any abstract sense—it’s Gary Tashjian, the owner, who makes that call each time.

FDA has directly rebutted the “Salmonella is natural, so it’s not really a problem” argument in writing, in one of its own Warning Letters to Tashjian: “The association between human illness or outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established… FDA considers a pet food to be adulterated if it is contaminated with Salmonella, regardless of the quantity or Salmonella serotype.” ^[11] That’s a direct, written rejection of the exact defense Tashjian has repeated for years.

The Cross-Contamination Problem: How Pathogens Spread Beyond the Pet Food Bowl

This is the part of the argument I feel most strongly about, and it’s why I’m so adamant about never bringing raw pet food into a home. Pets that eat contaminated raw food shed pathogens in their feces and saliva, often without showing any symptoms. That means it ends up in their bedding, on the couch, on your hands after you pet them, and, for the many families whose dogs and cats sleep in the bed with them, on the sheets and pillows too. If a child hugs or kisses the family dog or cat, or if the pet licks the child’s face, that’s completely normal, everyday affection, but it’s a direct route of exposure. If the dog does its business on the lawn and the kids play on that same lawn afterward, that’s another one. None of this requires anyone to be careless. It’s simply what happens when a pathogen-laden food enters a household.

I don’t think good hygiene fixes this. Washing bowls, disinfecting counters, and wiping down surfaces can reduce exposure, but they can’t eliminate it because contamination isn’t confined to the kitchen. It’s in the yard, the carpet, the pet’s fur, the places a dog or cat goes that no amount of countertop disinfecting will ever reach. This isn’t a risk that’s limited to households with someone elderly, immunocompromised, pregnant, or very young, though those groups face the most serious consequences if they’re exposed. Listeria, for instance, can cause miscarriage. It’s a risk for anyone in the house, human or pet, and it’s not one I think any family should decide is worth taking.

Why I Don’t Think Raw Pet Food Can Ever Be Made Safe

I want to be brief here, because this deserves its own full piece another time. The short version: only heat reliably kills Salmonella, Listeria, and E. coli. That’s the CDC’s and FDA’s position, not just mine. The U.S. meat industry, as a whole, is filthy, and that’s baked into how meat and poultry are regulated in this country: the USDA doesn’t treat Salmonella as an adulterant in raw meat and poultry, meaning contaminated product can legally be sold because the system assumes it will be cooked. Raw pet food removes that assumption entirely. This is why I don’t recommend it, full stop, regardless of the brand. It’s a subject I’ll come back to in more depth soon.

The Bottom Line

This case is a story about one man’s decade-long refusal to change course, and I’m glad to see the government finally act. But it’s also a case study in what happens when a regulator has real power and almost never uses it. The fact that the U.S. meat supply isn’t pathogen-free isn’t a failure of the system. It’s part of the system, a deliberate tradeoff built around the assumption that cooking will handle what inspection doesn’t catch. Raw pet food removes that assumption’s safety net entirely, and an FDA that treats mandatory recall as a last resort it almost never reaches for doesn’t do much to close that gap.

About Phyllis Entis of eFoodAlert

I want to close by giving Phyllis her due, separately from all the facts above, because she deserves more than a passing credit line.

Phyllis is a food safety microbiologist and publisher of eFoodAlert. I have immense respect for her work. Her daily coverage, cataloging, and reporting on essentially every pet food and human food recall happening across the U.S., Canada, and other English-language countries, with links out to European recall sources as well, is genuinely astounding, and no one else does what she does when it comes to recalls. Follow her: eFoodAlert | LinkedIn

She’s also the author of TOXIC: From Factory to Food Bowl, Pet Food Is a Risky Business, among other books about how broken the food system is. She asked me to review it when it came out, and I was glad to — it’s genuinely stellar, and if I could recommend just one book on pet food safety, this would be it.

Part of why she does this work is personal: she has a dog she loves dearly, and pet food safety is one of her real passions, not just a beat she covers. As I wrote at the time: “TOXIC… is a meticulous examination of the events surrounding the tragic consequences of tainted pet food. It’s based on exhaustive research and extensive references while avoiding the pitfall of using hysteria and hyperbole to dramatize the subject.” That’s still exactly how I’d describe it. If you want to go deeper on this subject than any single article can take you, buy it and read it. (Here’s my full review, if you want to read more.)

Source key for the timeline above (numbers correspond to the superscript citations in each entry):

1. Phyllis Entis, eFoodAlert, “DOJ, FDA take raw pet food company to court,” Aug. 11, 2026 (covers: 2011, 2016, Oct. 2017, Nov. 2017, Dec. 2018, July–Aug. 2022 illness details, Sept.–Oct. 2023, Aug. 2024 plant findings, Aug. 2025, and the 2016–Jan. 2026 cumulative total)
2. Pet Food Industry, “Darwin’s Natural responds to FDA advisory about Salmonella,” Aug. 18, 2023 (confirms Dec. 6–7, 2017, and Jan. 25, 2018 inspection dates, and the April 2, 2018 Warning Letter)
3. FDA.gov, “Updated: FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc.,” originally posted Feb. 13, 2018, updated Nov. 6, 2018
4. FDA.gov, “FDA Cautions Pet Owners Not to Feed Their Pets Three Lots of Darwin’s Natural Pet Products Raw Dog Food Due to Salmonella,” March 26, 2019
5. Phyllis Entis, eFoodAlert, “Raw pet food company sues to block FDA public health alert,” Aug. 2, 2022
6. Pet Food Processing, “Maker of Darwin’s Natural pet food warned for continued contamination,” March 27, 2023
7. FDA.gov, “FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products Pet Food Due to E. coli O157:H7 and Salmonella,” July 29, 2025
8. dvm360, “DOJ sues Washington pet food manufacturer over safety violations,” Aug. 2026 (references the September 2025 BioLogics Beef advisory)
9. The DOJ complaint against Arrow Reliance Inc. / Darwin’s Natural Pet Products, filed August 7, 2026 (Case No. 2:26-cv-02805, W.D. Wash.)
10. Pet Food Industry, “DOJ lawsuit seeks to halt Darwin’s raw pet food production, after decade of recalls,” Aug. 2026 (confirms the 2017 kitten genomic match, independently of eFoodAlert)
11. FDA Warning Letter to Arrow Reliance Inc., Feb. 16, 2023 (source for FDA’s direct written rebuttal of the “Salmonella is natural” argument)
12. FDA, Human Foods Complaint System (HFCS) Adverse Event Reports, May 2, 2017–May 1, 2018, raw consumer complaint database obtained via FOIA (source for the individual pet-owner complaints filed directly with FDA in April 2018)

Additional primary sources consulted:

• FDA Warning Letter to Arrow Reliance Inc., April 2, 2018
• Phyllis Entis, eFoodAlert, “Inspection results show Arrow Reliance (Darwin’s) is a repeat offender,” Oct. 16, 2024 (source for the detailed 2024 inspection findings)

Additional sources:

• Department of Justice press release announcing the complaint
• Bill Marler, Food Safety News: “Publisher’s Platform: Will the FDA use its recall authority to mandate a pet food recall due to Salmonella and Listeria?” (Sept. 2024)
• Bill Marler, Food Safety News: “Publisher’s Platform: FDA, why not use your Mandatory Recall Authority to protect Pets and Humans?” (Aug. 2025)
• FDA’s own constituent update on its mandatory recall authority, confirming it has issued a completed mandatory recall order only once since the Food Safety Modernization Act of 2011
• Pet Food Institute, “How Pet Food Product Recalls Work” — confirms a mandatory recall “has never occurred” for pet food specifically
• HHS Office of Inspector General, “Review of the Food and Drug Administration’s Monitoring of Pet Food Recalls” (2009), which found FDA lacked the authority to require pet food recalls at all before FSMA
• CDC, “About Pet Food Safety”
• FDA, “Get the Facts! Raw Pet Food Diets Can Be Dangerous to You and Your Pet”

Further reading — my own past coverage of Darwin’s and Bravo Packing:

• “Inspection of Darwin’s Reveals Revolting Conditions, Complaints of Ill and Dying Pets”
• “Sharp Bones, Plastic Bags and Metal Found in Darwin’s Dog Food; Complaints Date Back Months”
• “Raw Pet Food Maker Refuses to Issue Recall for Contaminated Cat and Dog Food, FDA Warns”
• “From Stable to Table: Horses Turned into Pet Food & Their Bones Sold as Dog Chews. In America. Right Now.” (Bravo Packing)
• “Maggot-Infested, Rotting Carcasses and Euthanized Animals Are Key Ingredients in U.S.’s Largest Pet Food Ingredient Company“ (Bravo Packing / Darling Ingredients)