Zuke’s withdraws dog treats from stores. FDA not informed


3rd Birthday #1 Aug 2005Zuke’s Mini Naturals dog treats have been withdrawn by the company.

The withdrawal follows a series of complaints posted on the websites of on-line retailers Amazon.com and Chewy.com over the last five months describing mold growth in unopened bags of the pet treats.

Some of the complaints described episodes of diarrhea and vomiting in dogs who were fed the treats.

According to the pet food retail chain, Pet Supplies Plus, the following products have been withdrawn:

  • Zukes Mini Naturals Chicken Recipe, 6 oz & 16 oz:- SKU Number 013423330517 & 013423330210
  • Zukes Mini Naturals Chicken Recipe, Sample Size (0.5 oz)
  • Zukes Mini Naturals Peanut Butter & Oats Recipe, 6 oz & 16 oz:- SKU Number 013423330524 & 013423330227
  • Zukes Mini Naturals Duck Recipe, 6 oz & 16 oz:- SKU Number 613423330533 & 613423330236
  • Zukes Mini Naturals Salmon Recipe, 6 oz & 16 oz:- SKU Number 013423330548 & 013423330241 
  • Zukes Mini Naturals Pork Recipe, 6 oz & 16 oz:- SKU Number 613423330557 & 613423330250
  • Zukes Mini Naturals Rabbit Recipe, 6 oz & 16 oz:- SKU Number 613423330564 & 613423330267
  • Zukes Mini Naturals Beef Recipe, 6 oz & 16 oz: SKU Number 613423330588 & 613423330601

The pet treats are sold nationwide through physical and online retailers.

Zuke’s, which is a subsidiary of Nestlé Purina PetCare, posted this notice on the “Contact Us” page of its website:

As you might have heard from your pet store, we are voluntarily removing Zuke’s Mini Naturals (all recipes) from sale due to a quality issue. While not a food safety issue, we took this proactive step with our retail customers and distributors to ensure our pet parents continue to have the best experience with our Zuke’s Mini Naturals products. If you aren’t completely satisfied with your recent Zuke’s Mini Naturals purchase, we are always happy to issue you a refund. To reach a member of our Pet Parent Relations team, please submit the form below or give us a call at 1-866-985-3364.

Zuke’s did not advise the FDA about this product withdrawal, nor was it obliged to do so, according to an agency spokesperson.

The FDA has received “a couple of complaints from pet owners involving moldy products and gastrointestinal signs such as vomiting and diarrhea, and is in the process of investigating those complaints.” The agency also has reached out to the manufacturer to learn more about the situation, including whether Zuke’s has received any complaints.

What consumers should do

  • Do not feed the withdrawn treats to your pet. Either discard them or return them to the retailer for a refund.
  • If your pet becomes ill after eating one of the withdrawn treats, consult your veterinarian.
  • Report any pet illness relating to consumption of a commercial pet food or pet treat to the FDA either through the agency’s online portal or by telephone.

Salmonella in multiple Midwestern Pet Foods products

Midwestern Pet Foods is recalling a long list of dog and cat foods due to potential Salmonella contamination, according to a notice posted late yesterday on the US Food and Drug Administration (FDA) website.

The recall, according to Midwestern, was initiated as a result of “a routine sampling program by the company which revealed that the finished products may contain the bacteria.”

The recall notice lists more than 140 individual items, with expiration dates spanning a nearly six-month period from April 26, 2022 to September 19, 2022.

Products included in the recall

  • Earthborn Holistic Adult Vantage
  • Earthborn Holistic Coastal Catch
  • Earthborn Holistic Great Plains Feast
  • Earthborn Holistic Large Breed
  • Earthborn Holistic Meadow Feast
  • Earthborn Holistic Ocean Fusion
  • Earthborn Holistic Primitive Feline
  • Earthborn Holistic Primitive Natural
  • Earthborn Holistic Small Breed
  • Earthborn Holistic Weight Control
  • Earthborn Holistic Western Feast
  • Earthborn Holistic Wild Sea Catch
  • Meridian Daybreak
  • Meridian Riverbend
  • Meridian Twilight
  • Pro Pac Adult Chunk
  • Pro Pac Adult Mini Chunk
  • Pro Pac Mature Adult
  • Pro Pac Performance Puppy
  • Pro Pac Ultimates Bayside Select
  • Pro Pac Ultimates Chicken & Rice
  • Pro Pac Ultimates Heartland Choice
  • Pro Pac Ultimates Lamb & Rice
  • Pro Pac Ultimates Large Breed Adult
  • Pro Pac Ultimates Large Breed Puppy
  • Pro Pac Ultimates Meadow Prime
  • Pro Pac Ultimates Overland Red
  • Pro Pac Ultimates Puppy
  • Pro Pac Ultimates Savannah Pride
  • Sportmix 24/20 Energy Plus
  • Sportmix Bite Size
  • Sportmix Canine X Chicken
  • Sportmix Gourmet Cat
  • Sportmix Hi Protein 27/12
  • Sportmix High Energy 26/18
  • Sportmix Maintenance 21/12
  • Sportmix Original Cat
  • Sportmix Stamina 24/18
  • Sportmix Wholeomes Large Breed
  • Sportmix Wholesome Performance Puppy
  • Sportmix Wholesomes Beef & Rice
  • Sportmix Wholesomes Cat
  • Sportmix Wholesomes Chicken & Rice
  • Sportmix Wholesomes Fish & Rice
  • Sportmix Wholesomes Grain Free Beef Meal & Chickpeas
  • Sportmix Wholesomes Grain Free Chicken Meal & Potato
  • Sportmix Wholesomes Grain Free Whitefish Meal & Potato
  • Sportmix Wholesomes Lamb & Rice
  • Sportmix Wholesomes Large Breed
  • Sportmix Wholesomes Performance Puppy
  • Sportmix Wholesomes Sensitive Lamb
  • Sportmix Wholesomes Sensitive Salmon
  • Sportstrail
  • Unrefined Lamb
  • Unrefined Rabbit
  • Unrefined Salmon
  • Venture Alaska Pollock Meal & Pumpkin
  • Venture Duck Meal & Pumpkin
  • Wholesomes Chicken &Rice
  • Wholesomes Fish & Rice

Please refer to the recall notice for a list of specific Lot codes/Expiration dates. Lot codes can be found on the back of the package, in the format “EXP AUG/02/22/M1/L#” in which the letter “M” indicates the Monmouth, Illinois, production facility.

The products were distributed to retailers nationwide and also were sold on-line.

There have been no reports of human or animal illnesses associated with the recalled products.

A backward glance

According to the FDA’s Inspection Classification database, this production facility was inspected on four separate occasions during 2008–2010. On each occasion, FDA inspectors observed sufficient deviations from correct practices to support a “Voluntary Actions Indicated” classification of the facility.

This recall represents the second major recall of Midwestern Pet Foods dry dog and cat foods in less than six months.

On December 30, 2020, the company announced a recall of six Sportmix products, manufactured in its Chickasha, Oklahoma, facility, due to excessive aflatoxin levels in the products. That recall was expanded on January 11, 2021, to include additional products and expiration dates.

What consumers should know

  • Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. 
  • Infected pets may shed Salmonella in their stools, whether or not they are showing symptoms of active illness.
  • Household members may come into contact with Salmonella through handling the contaminated pet food or by contact with their infected pet. Ensure that all household members pay careful attention to personal hygiene to avoid infection.
  • People infected with Salmonella may show symptoms including: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Contact your healthcare provider if you or any household member develops these symptoms.
  • You can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators.

Why Recalls Happen: A Sunshine Mills, Inc. Case Study, Part 1 (Aflatoxins)

Sunshine Mills, Inc. (Sunshine) is a manufacturer of pet foods and pet treats, with headquarters in Red Bay, Alabama, and production facilities in six states.

What happened?

On April 3, 2020, Sunshine’s Tupelo, Mississippi, facility sampled, tested AND ACCEPTED a bulk load of yellow corn that exceeded the company’s rejection level for aflatoxin.

The aflatoxin-contaminated batch of corn was used in the manufacture of multiple pet foods between April 3rd and April 5th.

On August 17, 2020, the Louisiana Department of Agriculture and Forestry detected aflatoxin in a sample of Family Pet brand dog food manufactured by Sunshine on April 5th. The aflatoxin level that Louisiana found was 82.4 parts per billion (ppb)—more than four times FDA’s action level of 20 ppb.

On September 2, 2020, Sunshine recalled three products due to the presence of aflatoxin “potentially above the acceptable limit.”

On September 8, 2020, the US Food and Drug Administration (FDA) initiated an inspection of Sunshine’s Tupelo facility.

One month later, on October 8, 2020, Sunshine announced an expansion of its previous recall to encompass an additional twenty-one products that were manufactured using the same batch of corn used in the manufacture of the aflatoxin-contaminated Family Pet dog food.

How did this happen?

According to the FDA inspector’s observations and the company’s formal response (both obtained in response to a Freedom of Information Act request), there were multiple failures, including:

  • The lab technician who carried out the aflatoxin test on the incoming corn did not follow Sunshine’s documented testing procedure and also incorrectly recorded the test result.
  • Sunshine never verified the performance and calibration of the mycotoxin-detection equipment used to test for aflatoxins.
  • Printouts from the mycotoxin-detection equipment were not legible, as the printer had cut off the top of the printed digits, resulting in numerous transcription errors when the data were recorded in the test result logs.
  • The company never validated its sampling method, including how large a sample should be drawn from each bulk grain shipment or how the sample should be collected to ensure that it represents the entire shipment.

What are aflatoxins?

Aflatoxins are a group of naturally occurring toxins produced during the growth of the mold, Aspergillus flavus, on certain agricultural commodities, including corn. They are carcinogens and mutagens, and also can cause liver failure in animals.

Aflatoxin contamination of pet foods resulted in pet illnesses and deaths and multiple recalls of pet foods in 1998, 2005, 2011 and 2013, according to FDA’s Compliance Policy Guide.

The FDA has established action levels for the presence of aflatoxins in human food, animal feeds and pet foods, including an action level of 20 ppb in pet foods.

Common symptoms of aflatoxin poisoning in pets are sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea. Some pets may suffer liver damage without displaying any symptoms.

Could this have been avoided?

  • IF the lab technician had been properly trained and supervised, the contaminated bulk grain shipment would have been rejected.
  • IF the equipment had been properly calibrated and certified, the aflatoxin result would have been accurate.
  • IF the Quality Assurance Supervisor had paid attention to equipment maintenance, the printouts would have been legible.
  • IF Sunshine’s preventive controls had included aflatoxin testing for the corn-based ingredient, the problem could have been caught before the ingredient was used in production.
  • IF the bulk grain sampling and testing methods had been properly validated, a contaminated shipment would be more likely to be caught and rejected.

Was this an isolated incident?

In 2018, this same Sunshine facility was responsible for the production of a number of dog foods that contained excessive levels of vitamin D.

An inspection of the manufacturing facility revealed that the company did not have adequate procedures in place to ensure that the vitamin D ingredient it purchased from its supplier met all ingredient specifications.

Sunshine used a vitamin D ingredient that was not accompanied by a Certificate of Analysis and did not perform any lab tests of its own to verify that the ingredient was of the correct concentration.

When Sunshine was notified by one of its private-label customers of a consumer complaint reporting an ill dog, the company determined that the complaint was valid, but did not immediately notify FDA as it was required by FDA regulations.

In its formal reply to the FDA inspection observations, Sunshine blamed its vitamin supplier for the incorrect shipment, and claimed that it believed the owner of the private-label brand would make a report to FDA.

Stay tuned for Part 2 of this case study, which will examine the story behind Sunshine’s 2020 recall of Salmonella-contaminated pet food.

Note: This story is based on information retrieved from the FDA website and on documents obtained as a result of Freedom of Information Act requests.