Recalls and Alerts: April 27–28, 2023

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

Allergy Alert: GHSW, LLC recalls Turkey and Havarti Sandwiches (8.55 oz; All sell-by dates up to and including 4/29/23; UPC 8 2676615584 2) due to undeclared sesame in the bread.

Allergy Alert: GH Foods CA, LLC recalls Turkey and Havarti Sandwiches (8.55 oz; All sell-by dates up to and including 4/29/23; UPC 8 2676615584 2) due to undeclared sesame in the bread.

Allergy Alert: GHGA, LLC recalls Turkey and Havarti Sandwiches (8.55 oz; All sell-by dates up to and including 4/29/23; UPC 8 2676615584 2) due to undeclared sesame in the bread.

Food Safety Recall: General Mills recalls Four Gold Medal Unbleached and Bleached All Purpose Flour Varieties (multiple pack sizes; Better if used by March 27, 2024, and March 28, 2024) due to possible Salmonella contamination. Please refer to the recall notice for a complete list of affected products.



Food Safety Recall: Super C (Saint-Charles-Borromée, QC) recalls Bœuf haché mi-maigre / Medium lean ground beef (Sold 24 April 2023), because the product might not be safe to consume.



OUTBREAK INVESTIGATION (Denmark): The Statens Serum Institut is investigating an outbreak of 16 confirmed cases of Salmonella Muenchen illness reported in March and April 2023. The 16 cases are spread over five regions of the country, with half of them being concentrated in the capital region. No specific food source has yet been identified for this outbreak.

Allergy Alert (Germany): Nordlicht Naturkost GmbH recalls Biogreno Bio Leinsamen geschrotet / Organic ground linseed (500g; Lot 914005; Best before 15.12.2023) due to undeclared mustard.

Allergy Alert (Hungary): Bergland Hungaria Kft. recalls Bergland Gluténmentes tallér köménymaggal / Gluten-free biscuit with cumin seeds (100 g; Best before 23.11.2023) and Gluténmentes tallér medvehagymával / Gluten-free biscuit with shallots (100 g; Best before 20.01.2024) due to undeclared gluten.

Allergy Alert (Ireland): FSAI warns of possible undeclared mustard in True Natural Goodness Organic Brown Linseed (Flaxseed) (5 kg; Best before 20/12/2023 to 07/01/2024 inclusive) and Green Age Salad Mix Seeds & Kernels (250g; Batch code 2233; Best before 24/08/2023).

Allergy Alert (Italy): Euroverde Soc. Agr. S.r.l. recalls Il Viaggiator Goloso brand Passato di verdure con zucchine e patate / Potato purée with zucchini and potatoes (620g; Lot 220103COD; Use by 19-05-2023) due to undeclared gluten.

Allergy Alert (Italy): Food For All snc recalls PUREZZA BIO brand SEMI DI LINO SCURI BIOLOGICI / Organic dark linseed (200g; Use by 03/09/2024) due to undeclared mustard.

Allergy Alert (Italy): Food For All snc recalls PENSA BIO brand SEMI DI LINO SCURI BIOLOGICI / Organic dark linseed (500g; Use by 03/09/2024 and 13/10/2024) due to undeclared mustard.

Allergy Alert (Italy): Food For All snc recalls PUREZZA BIO brand MIX SEMI TOSTATI BIOLOGICI / Organic roasted seeds mix (200g; Use by 29/05/2024) due to undeclared mustard.

Allergy Alert (Netherlands): Albert Heijn recalls AH Saladbowl green bowl (Best before 30-04-2023) due to undeclared sesame.

Allergy Alert (Norway): Rema 1000 recalls Kolonihagen brand Linfrø økologisk / Organic linseed (350g; Batch P-007819; Best before 11/10/2023, 12/10/2023, 13/10/2023, 15/10/2023, 17/10/2023) due to undeclared mustard.

Food Safety Recall (Austria): Wojnar’s Wiener Leckerbissen Delikatessenproducer GmbH recalls BILLA SCHINKEN EI WRAP / Ham and egg wrap (170g; Best before 08.05.2023) due to possible Listeria monocytogenes contamination.

Food Safety Recall (Belgium): AFSCA recalls Taifun brand Tofu-Terrine Graffiti (200g; Lot L220; Best before 02/05/2023) due to possible foreign matter contamination (pieces of plastic).

Food Safety Recall (France): EARL LA BREBIDORE recalls Fromages de brebis / Sheep milk cheeses (Lot 97; Sold from 12/04/2023 to 17/04/2023) due to Salmonella contamination.

Food Safety Recall (France): COOP ELEVAGE AVICOLE ET CUNICOLE GUYANE CACG recalls CACG brand Oeuf coquille / Shell eggs (Cartons of 12 and flats of 30; Lot 2FRIHT01; Use by dates between 01/05/2023 and 04/05/2023) because the flock of laying hens was infected with Salmonella Typhimurium.

Food Safety Recall (France): MARIE MORIN-FRANCE recalls Marie Morin brand MOUSSE CHOCOLAT A L’ANCIENNE / Old-fashioned chocolate mousse (100g and 2 x 100g; Lot 431100002; Use by 11/05/2023) due to foreign matter contamination (glass splinters).

Food Safety Recall (France): CYDEL CARREFOUR-MARKET recalls JAMBON CUIT SUPERIEUR AVEC COUENNE VENDU AU RAYON CHARCUTERIE COUPE DU MAGASIN MARKET RIOM ES MONTAGNES ENTRE LE 12 AVRIL ET LE 19 AVRIL 2023 / Superior cooked ham with rind (Sold by the slice between 12 April and 19 April) due to possible Listeria monocytogenes contamination.

Food Safety Recall (France): FROMAGERIE DE LA CHAPELLE SAINT JEAN recalls fromagerie de la chapelle saint jean brand Rollot brayon raw milk cheese (200g heart-shaped; Lot 132; Best before 29/05/2023) due to Listeria monocytogenes contamination.

Food Safety Recall (France): BELMARO INTERMARCHE recalls steak haché à la demande / ground beef (Carcass lot B914000021821) due to Listeria monocytogenes contamination.

Food Safety Recall (Germany): dm-drogerie markt recalls dmBio Erdmandelmehl / Tigernut flour (300g; Best before 30.04.2024) due to possible Salmonella contamination.

Food Safety Recall (UK): Lactalis McLelland Ltd recalls three varieties of goat milk cheese due to possible Listeria monocytogenes contamination. Please refer to the recall notice for a complete list of affected products.

Australia and New Zealand

Allergy Alert (Australia): Usha Food Imports Pty Ltd  recalls Jabsons Tandoori Roasted Peanuts (140g; Best before 29 February 2024; Product of India) due to undeclared milk.

Allergy Alert (New Zealand): A B Food Industries Ltd recalls Wild Snack NZ brand Chicken Cassava Vege Chips (100g; Best before 06 AUG 23 and 10 SEP 23) due to undeclared milk.

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Sunday Supplement: Darwin’s Defies FDA (Op-Ed)

In a written response to a February 16, 2023, Warning Letter issued by the US Food and Drug Adminstration (FDA), Gary Tashjian, President of Arrow Reliance, Inc. (dba Darwin’s Natural Pet Products) has effectively told the federal agency to take a hike.

Tashjian’s letter to the FDA was obtained by eFoodAlert in response to a Freedom of Information Act request.

The FDA Warning Letter was issued following an August–September 2022 inspection of the company’s raw pet food manufacturing facility, located in Tukwila, Washington, and the finding of two different Salmonella serotypes (Typhimurium and Kentucky) in samples of the company’s products.

In the Warning Letter, the FDA cited three violations of the Federal Food, Drug & Cosmetics Act and regulations (FD&C Act).

  • Adulterated animal food (due to presence of Salmonella)
  • Use of Peroxyacetic Acid (PAA) in a manner not generally recognized as safe under the FD&C Act
  • Failure to register as a Food Facility as required under the FD&C Act

Tashjian’s formal response characterized all of the FDA’s citations as “…arbitrary and capricious, in excess of statutory authority and otherwise unlawful.”

Tashjian’s arguments


The 2022 inspection that culminated in the Warning Letter was initiated in response to a consumer complaint. A cat owner had fostered four kittens, and fed about a tablespoon full of a Darwin’s adult cat food to three of them.

All three kittens who ate the food became ill, and a stool culture from one of the kittens yielded Salmonella. The kitten that did not eat the food remained healthy. Salmonella also was recovered from a sample of the same production batch that was fed to the kittens.

Over the course of the past several years, Tashjian has repeatedly rejected the FDA’s policy of zero-tolerance for Salmonella and other pathogens in pet foods and treats, including raw pet food products.

His argument is that the FDA must shoulder the burden of proof in each individual instance where a pathogen is found.

According to Tashjian, it is not enough to find Salmonella in one of his company’s finished products, even when the serotype in question annually makes the CDC’s list of ‘top ten’ Salmonella serotypes associated with human illnesses (as is the case with Salmonella Typhimurium).

Tashjian has taken the position that the agency must document that the quantity of the precise genetic strain of Salmonella found in the sample will cause illness in an animal or a person.

Tashjian’s response to the contamination cited in the Warning Letter is (a) that the strain of Salmonella recovered from the sick kitten was not typed genetically and may have come from somewhere other than the food, and (b) that the owner should not have fed the product to her kittens, as it was labeled for adult cats.

Use of peroxyacetic acid (PAA)

The FD&C Act and its associated regulations includes a list of food additives and ingredients that are “generally recognized as safe” (GRAS) for specific circumstances and at specific maximum concentrations.

Peroxyacetic acid, which is formed when acetic acid is allowed to combine with hydrogen peroxide, is GRAS for certain food applications, including as an antimicrobial secondary direct food additive in human food, at a maximum concentration of 220 parts per million (220 ppm).

Darwin’s uses PAA as a pathogen mitigation tool in its raw pet foods, even though the chemical has not been approved for that purpose, according to the Warning Letter. Furthermore, the company increased the concentration of PAA added to its products to an amount exceeding the 220 ppm that is permitted under the GRAS regulation.

And it did so without submitting any documentation that the level it is using is safe for dogs and cats to consume.

Tashjian’s rebuttal is two-fold.

  • PAA is used as a processing aid in USDA-inspected plants and any raw poultry purchased by Darwin’s would likely have been treated with this product.
  • The two components of PAA are both GRAS for pet food; therefore it is unnecessary for the combination of the products to be GRAS.

He is silent on the company’s use of PAA at a higher concentration than has been recognized as safe for any food applications.

Food Facility Registration

Finally, Tashjian rejects the FDA’s assertion that he is obliged to register Arrow Reliance, Inc. as a Food Facility, arguing that his company is exempt from the requirement, as it sells its products directly to consumers and is, therefore, a retail food establishment.

In support of his position, he cites the FDA response to comments published in the Federal Register concerning the definition of “retail food establishment.” (see Federal Register 81(135):45923. 14 July 2016)

My rebuttal

Tashjian’s cavalier dismissal of the risk to human and animal health associated with Salmonella-contaminated pet food is disingenuous, at best.

His stance on the presence of Salmonella (and other pathogens) in his raw pet foods is akin to a driver who, having been ticketed for doing 90 miles an hour in a 60 mile-an-hour zone, demands that the police officer provide proof that his speed was unsafe for that specific stretch of road in the specific make and model of vehicle under the exact time of day and road conditions at the moment he was ticketed.

Pathogens in pet food

The presence of Salmonella in any pet food or pet treat, raw or processed, presents a risk to human and pet health.

While not all Salmonella serotypes and strains are alike in their ability to cause infection, low numbers of Salmonella have been documented to do so, depending upon the susceptibility of the person or animal who is exposed to the microbe and the nature of the food ingested, especially the fat and protein content of the food.

As I discuss in my new book, TOXIC, Salmonella-contaminated kibble has been responsible for two multi-state Salmonella outbreaks in the United States since 2006. Salmonella-contaminated pet treats have caused multiple outbreaks of human illness in the United States and Canada since the 1990s.

Documenting Salmonella infections in animals is more difficult than in humans, because there is no requirement for animal illnesses to be reported to the FDA, even when a veterinarian has made a diagnosis based on lab culture results. Nevertheless, on two widely separate occasions (2017 and 2022), a direct link was established between a Salmonella-infected animal and a Salmonella-contaminated Darwin’s raw pet food.

Peroxyacetic acid as a pathogen mitigation

There is a process in place for a company to submit documentation demonstrating the safety and efficacy of a new food additive or a new use for an existing additive. The FDA reviews the documentation and if the data support the proposal, the agency will grant its approval.

That did not happen in this case.

Darwin’s arbitrarily and unilaterally increased the amount of PAA it adds to its products to a level beyond the highest concentration that had been approved as safe for any food application.

Food Facility Registration

Is Arrow Reliance really exempt from the requirement of food facilities to register with the FDA?

The exemption on which Tashjian bases his claim is a “retail establishment exemption.” According to Tashjian, because Darwin’s sells directly to customers, the company meets the definition of a retail establishment. He cites a specific statement made by the FDA and published in the Federal Register (volume 81(135), page 45923) to support his claim.

Tashjian quotes the statement as including in the exemption “…larger establishments [that] can reach consumers on a national level”

Read in isolation, the statement appears to support Tashjian’s contention. However, when taken in context, it is clear that the FDA is referring to “…direct-to-consumer sales of foods from local farms and establishments closely associated with farms.”

Arrow Reliance is not located on a farm, owned by a farm, or closely associated with farms. The company is a free-standing, independent manufacturer and processor of raw pet foods.

What next for the FDA?

Science, the law and common sense come down on the side of the FDA.

In my opinion, the agency has two choices:

  1. Continue along the well-trodden path of responding to future consumer complaints–and there will be future consumer complaints–with follow-up inspections, documentation of violations, and public alerts, all of which the company will either ignore or contest, or
  2. Solicit the assistance of the Department of Justice and apply for an injunction to compel the company to adhere to the same rules as every other raw pet food producer must follow.

If the FDA does not take strong action against Arrow Reliance, a company that routinely over the years has refused to cooperate with FDA and state investigators, has applied to the courts in a failed attempt to prevent the FDA from exercising its legal authority, and has ignored or deliberately misconstrued the clear intent of various provisions of the FD&C Act and regulations, the agency will lose all credibility both with the industry it is charged with regulating and with the public it is supposed to protect.

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Sunday Supplement: Primal Pet ignores pathogen problem

Between August 2021 and August 2022, Primal Pet Foods, Inc.’s internal finished product testing program found forty-nine (49) pathogen-positive finished product samples, according to a Warning Letter released this week by the U.S. Food and Drug Administration (FDA).

Primal Pet Foods, Inc. (Primal) is a manufacturer of raw frozen and raw freeze-dried dog and cat foods, toppers, and treats based in Fairfield, California.

On July 6, 2022, Primal announced a recall of a single production lot of Raw Frozen Primal Patties for Dogs, Beef Formula (Lot #W10068709) after routine sampling by the FDA found Listeria monocytogenes in the product.

As a follow-up to the recall, the FDA visited the company’s Fairfield manufacturing facility on July 14, 2022, to begin an inspection that continued until October 11th.

During the course of the inspection, FDA investigators documented a large number of troubling issues

What the FDA found

The failures summarized in the Warning Letter and on the FDA Inspections Database include problems with preventive controls, supplier verification, record keeping, and inadequate monitoring.

Preventative controls that did not prevent pathogens

Primal’s food safety program includes adding a probiotic to its freeze-dried products as a preventative control for Salmonella.

Probiotics are so-called “good” bacteria found in the digestive system. They play an important role in digestion and also help to prevent pathogens from taking up residence in the large intestine.

When the FDA reviewed Primal’s documentation purporting to validate the effectiveness of the probiotic, they found significant flaws in the validation study, including the use of a relatively insensitive method for detecting residual Salmonella.

The FDA maintains a zero-tolerance policy for Salmonella and other pathogens in all pet foods, and the standard method used by government and industry labs is able to find a single living Salmonella cell in 25 grams of sample. Yet the method used by Primal’s lab to support their validation study was only able to find Salmonella if it was present at a level of 10 or more Salmonella cells per gram.

Furthermore, the company offered no evidence that its probiotic control would have any effect at all on other pathogens, such as Listeria monocytogenes or E. coli O157:H7.

As further proof that the probiotic control was not working, the FDA cited Primal’s own records of 49 pathogen-positive production lots over a one-year period. An average of just under one contaminated batch per week.

Inadequate response to contaminated and out-of-compliance products

Primal’s standard operating procedure specified a maximum level for Vitamin D of 3000 International Units per kilogram (IU/kg). Yet the company shipped a batch of freeze-dried dog food containing 3410 IU/kg–more than 10% above the maximum specified level. And it did so before the sample of this batch even reached its third-party lab for testing.

Primal’s standard operating procedure also specified a minimum level for thiamine–an essential vitamin for cats–of 5.6 mg/kg in its feline diets. Yet the company shipped a batch of freeze-dried cat food containing only 3.96 mg/kg. Again, the product was shipped even before the sample reached the lab.

Primal found Salmonella and/or Listeria monocytogenes in its finished products on 49 occasions during a one-year period, according to the company’s own records. There is no information in the Warning Letter as to what happened to those 49 contaminated production batches.

The only publically announced product recall occurred as a result of the FDA having found Listeria monocytogenes in a routine surveillance sample.

After learning of the FDA’s findings, the company issued a public recall. Yet it took no steps to evaluate the safety of other pet foods manufactured on the same production line immediately before and after the recalled batch.

Unhelpful response to records requests

Primal did not promptly provide all required records when requested to do so by the FDA investigator, impeding the ability of the FDA to complete its inspection and evaluation in a timely fashion.

It is unclear from the limited information available in the Warning Letter and the FDA Inspections Database whether or not the company eventually supplied all of the requested documentation.

What happens next?

The Warning Letter was dated February 21, 2023.

The company was been given the standard fifteen (15) working days following receipt of the letter in which to respond in writing with specific steps taken to correct the list of violations, including copies of related documentation to support its corrective measures.

The ball is now in Primal’s court.

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