Status: Advisory active; manufacturer declined FDA-requested recall. Across 2025, the FDA detected multiple pathogens across multiple Darwin’s Natural Pet Products dog food lots. July 29, 2025: beef dog food sample positive for E. coli O157:H7, chicken and duck samples positive for Salmonella. September 24, 2025: two lots of Darwin’s BioLogics All-Natural & Grain-Free Beef Recipe (lot 11895 manufactured July 29, 2025; lot 11826 manufactured July 7, 2025) positive for Listeria monocytogenes, with one of the lots additionally positive for Salmonella. The FDA recommended Arrow Reliance, Inc. recall the affected lots; the firm declined. Arrow Reliance notified customers about the Listeria detection but did not initially disclose the Salmonella finding.

What was recalled

Darwin’s Natural Pet Products is sold online through a subscription service in frozen 2-pound packages. The FDA detection sequence across 2025 involved multiple separate sampling events. On July 29, 2025, the FDA notified pet owners that a sample of Darwin’s Natural Pet Products beef dog food tested positive for Escherichia coli O157:H7, a Shiga-toxin-producing E. coli strain associated with severe human disease. One sample of Darwin’s chicken dog food tested positive for Salmonella Infantis and one sample of Darwin’s duck dog food tested positive for Salmonella Hadar.

On September 24, 2025, the FDA issued a follow-up advisory covering two lots of Darwin’s BioLogics All-Natural & Grain-Free Beef Recipe for Dogs: lot 11895 (manufactured July 29, 2025) positive for both Listeria monocytogenes and Salmonella, and lot 11826 (manufactured July 7, 2025) positive for Listeria monocytogenes. The FDA published its formal notice at its Outbreaks and Advisories archive. The FDA recommended Arrow Reliance, Inc. (parent of Darwin’s) recall the affected lots. Arrow Reliance declined. The company sent a letter to customers notifying them about the two lots testing positive for Listeria but did not initially inform customers about the Salmonella finding in one of the same lots.

Why it was recalled

Raw pet food carries inherent pathogen exposure risk because the format lacks the high-temperature kill step that kibble extrusion provides. Darwin’s Natural Pet Products produces frozen raw dog food and historically has been the subject of repeated FDA pathogen detections; the September 2025 detection was at least the second multi-pathogen FDA event in 2025 alone (July 2025 already produced E. coli O157:H7 and Salmonella positives). The company’s decision to decline the FDA-requested recall is unusual and important: most manufacturers issue voluntary recalls in response to FDA pathogen-detection advisories. FDA regulatory authority over pet food recalls is narrowly scoped under FSMA, so when a company declines, the FDA’s primary recourse is public advisory and consumer notification — both of which the September 2025 actions exercised.

Health risks for your pet

The September 2025 dual-pathogen Listeria + Salmonella event in lot 11895 is the most concerning Darwin’s detection of the 2025 sequence. Listeria monocytogenes causes listeriosis, which in dogs and cats can present as diarrhea, vomiting, fever, and in severe cases septicemia or CNS involvement. In humans, listeriosis is a serious disease: pregnant women face miscarriage and neonatal-infection risk, infants and the elderly face high mortality from septicemia and meningitis, and immunocompromised adults face elevated severe-disease risk. E. coli O157:H7 (the July 2025 finding) is the Shiga-toxin-producing strain responsible for hemolytic uremic syndrome (HUS) in children — the food safety attorney Bill Marler tracked the case via his blog and noted a separate HUS case in a child consistent with Darwin’s exposure. The Salmonella Infantis and Salmonella Hadar serotypes in the chicken and duck samples are clinically significant in both pets and humans. The repeated multi-pathogen detection pattern across 2025 indicates a systemic process gap, not a single-batch event.

What to do if you bought affected product

If you have Darwin’s BioLogics All-Natural & Grain-Free Beef Recipe for Dogs lot 11895 or lot 11826 in your freezer, do not feed it and dispose of the product securely. The same caution applies to any Darwin’s beef, chicken, or duck dog food from the July 2025 production window covered by the earlier FDA advisory. Wash food bowls, prep surfaces, and hands with hot soapy water. If your dog ate Darwin’s product and shows diarrhea (especially bloody), vomiting, fever, or lethargy, contact your veterinarian; mention the recent raw-food exposure. Pregnant women, infants, the elderly, and immunocompromised adults in households feeding any raw pet food should avoid handling the food directly given the documented Listeria risk pathway. Given Arrow Reliance’s decision to decline the FDA-requested recall, the FDA continues to advise not to feed the affected lots even though they remain available for retail sale.

How this affects KibbleIQ’s grade

Darwin’s Natural Pet Products is not in the KibbleIQ scored database — our methodology v15 covers commercial dry kibble, fresh cooked food, and selected raw-coated kibble per our published methodology; standalone raw frozen is a distinct format that the rubric does not yet specifically score. The 2025 sequence (E. coli O157:H7 + multi-serotype Salmonella in July, dual Listeria + Salmonella in September) reflects a systemic process gap rather than a single-batch failure. The company’s decision to decline the FDA-requested recall is a significant quality-systems concern that distinguishes Darwin’s response from manufacturer-initiated voluntary recalls in the same outbreak window (Answers, Bravo Packing, Stella & Chewy’s, Albright’s). Pet owners considering Darwin’s today should review the active FDA advisory status and weigh the documented repeated pathogen-detection rate against the brand’s subscription distribution model.