After Listeria, Salmonella and E. coli positive samples, and HUS in a child, why no mandatory recall by the FDA?

In less than one year Darwin’s Natural Pet Products have been found to be contaminated with Listeria, Salmonella (three times) and E. coli O157:H7.  This year Dawin’s pet food has been epidemiologically and genetically linked to kidney failure in a young child in Utah.

Yet, although Darwin’s has refused voluntary recalls in both instances, the question must be asked, why has the FDA not used its mandatory recall authority?

First the recalls and the outbreak.

On September 20, 2024, the U.S. Food and Drug Administration cautioned pet owners that FDA samples of five Darwin’s Natural Pet Products raw cat and dog food made by Arrow Reliance, Inc. tested positive for Salmonella and a sixth FDA sample tested positive for Salmonella and Listeria monocytogenes (L. mono). 

FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Selections Pet Food Due to Salmonella and Listeria monocytogenes

• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
  • Lot No: 10832 MFG. Date: Jul 25, 2024
• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
  • Lot No: 10856 MFG. Date: Aug 04, 2024
• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats
  • Lot No: 10890 MFG. Date: Aug 13, 2024
• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
  • Lot No: 10828 MFG. Date: Jul 24, 2024
• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
  • Lot No: 10844 MFG. Date: Jul 30, 2024
• Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Dogs
  • Lot No: 10887 MFG. Date: Aug 12, 2024

The FDA recommended that Arrow Reliance, Inc. recall all six lots of product. To date, the firm has not recalled the affected products and could continue to distribute them.

On July 29, 2025, the FDA is cautioned pet owners that a sample of Darwin’s Natural Pet Products beef dog food made by Arrow Reliance, Inc. tested positive for Escherichia coli (E. coli) O157:H7 that is associated with a human illness. In addition, one sample of Darwin’s chicken dog food and one sample of Darwin’s duck dog food tested positive for Salmonella Infantis and Hadar, respectively.  Closed product from the three affected lots, which were obtained from the household freezer of the ill human, was tested by a private third-party laboratory in May and June 2025.

FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products Pet Food Due to E. coli O157:H7 and Salmonella

• Darwin’s Natural Pet Products, BioLogics All-Natural and Grain Free, Beef Recipe for Dogs
  • Lot 10662, MFG Date: May 30, 2024
• Darwin’s Natural Pet Products, BioLogics All-Natural and Grain Free, Chicken Recipe for Dogs
  • Lot 10683, MFG date: June 05, 2024
• Darwin’s Natural Pet Products, Natural Selections Duck Recipe for Dogs
  • Lot 10638, MFG date: May 22, 2024

The FDA recommended that Arrow Reliance, Inc. recall the product lots that tested positive for E. coli O157:H7 and Salmonella. To date, the firm has not recalled the affected products. These products, which were manufactured in May or June 2024, were sold frozen, have no expiration date on the label, and could still be in consumers’ freezers.

What Authority does the FDA have to mandate a recall?

The FDA’s mandatory food recall authority went into effect when FSMA was enacted on January 4, 2011. Section 423 of the FD&C Act, as added by section 206 of FSMA, gives the FDA the authority to order a responsible party to recall an article of food where the FDA determines that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the FD&C Act [21 U.S.C. § 343(w)] and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).

Before the FDA can use its mandatory recall authority under section 423 of the FD&C Act, the FDA must make the determination that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act. The FDA must also decide that there is a reasonable probability that the use of or exposure to such food will cause SAHCODHA.

Once the FDA has determined that the criteria for a mandatory recall have been met, the FDA must first provide the responsible party (as defined in section 417(a)(1) of the FD&C Act) with an opportunity to voluntarily cease distribution and recall the article of food. The FDA will notify the responsible party of this opportunity in writing using an expeditious method of delivery. If the responsible party refuses or does not voluntarily cease distribution and recall the article of food within the time and manner prescribed by the FDA, if so prescribed, the FDA may order the responsible party to cease distributing the article of food, order the responsible party to give notice to certain other persons to cease distributing the article of food, and give the responsible party an opportunity to request an informal hearing to be held not later than 2 days after the issuance of the order.

After these steps are completed, the FDA may order a recall under section 423(d) of the FD&C Act if it is determined that the removal of the article from commerce is necessary. Only the FDA Commissioner has the authority to order a recall under section 423(d). If necessary, recall orders under section 423(d) shall be vacated by the Commissioner.

In accordance with section 423(g) of the FD&C Act, the FDA will ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, to provide notification to affected consumers and retailers. The publication will include, at a minimum, the name of the article of food subject to recall, a description of the risks associated with the food, and to the extent practical, information about similar articles of food that are not affected by the recall.

Am I missing something here?

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/after-listeria-salmonella-and-e-coli-positive-samples-and-the-hus-in-a-child-why-no-mandatory-recall-by-the-fda/