Below, weve outlined the four aspects that we addressed in our response to the FDA: (1) PREVENTIVE CONTROLS. No other lot codes or Primal products are impacted by this announcement. As a result, the company has recalled a single lot of 6-pound Raw Frozen Primal Patties for Dogs. Fairfield, CA 94534-1790 People can become sick by handling. So, more pet foods than the ones listed below have been recalled in the past five years, but those recalls have since been terminated. While not required from a regulatory standpoint, we have enhanced our nutritional testing to include a Test & Hold program. A large breed dog (up to 75 pounds) should eat up to 2 cups of dry food per day. If you buy something from a link on our site, we may earn a commission. During the FDA inspection, we provided a high-level summary from the third-party validation of the effectiveness of probiotics for safety. Tesco is the. The firm does not perform cleaning between batches of the same recipe and only performs a (redacted) when transitioning between different recipes. In addition, you are updating your good manufacturing practices and will provide training on your new procedures, increase your environmental monitoring swab sites, and will provide training on your CAPA procedures. No other lot codes or Primal products are impacted by this announcement. Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt; 03/10/2023: Purina: Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that . The food was recalled after a state surveillance sample found salmonella and listeria in multiple 1-pound packages of Beef HVM. The company uses a test and hold protocol to ensure that all products test negative for harmful bacteria before being released for sale. This formula is curated with fresh lamb, a rich source of delicious protein. This is a grain-free formula and is also free of any legumes. However, we failed to provide the detailed scientific studies that demonstrate the effectiveness of probiotics in our freeze-dried and frozen products using our equipment parameters. Ingesting elevated amounts of choline chloride could lead to illness or even death. The validation study did not report whether Salmonella was detected below (b)(4) CFU/g. Be sure to thoroughly wash your hands and clean your pups bowls and any other surfaces the food touched. We are confident we are taking the right steps to ensure we are continuing to make raw food even safer for our consumers and their pets. TI1 3/APRIL/2020 TI2 3/APRIL/2020 TI3 3/APRIL . Food & Drug Administration On September 2, 2020, Sunshine Mills announced a recall of certain pet food products after a retail product sample was found by the Louisiana Department of Agriculture & Forestry to contain. In February, the United States Food and Drug Administration (FDA) issued a warning letter to Primal Pet Foods after agency representatives inspected Primal Pet Foods' manufacturing facility in Fairfield, California in 2022. Through a recent product quality review process, we have determined that 5 specific Primal Canine and Feline Freeze-Dried Poultry Formulas were produced outside of our grind size . This voluntary recall is a result of routine sampling by the U.S. Food and Drug Administration, which revealed a positive result for Listeria monocytogenes in one sample from one lot of Raw Frozen Primal Patties for Dogs Beef Formula. The company distributed sixty-six cases (396 units) of this single lot of Raw Frozen Primal Patties to Maryland, Georgia, Texas, and British Columbia, in late April 2022. Start your day with heartwarming and hilarious animal stories that will make you fall in love. Primal dog food uses bones, meat, and organ meat from these protein sources for its recipes. You identified (b)(4) as the preventive control for frozen products and probiotic inclusion as the preventive control for freeze dried products. In addition, your firm failed to reduce the likelihood the problem will recur as evidenced by your testing showing four lots of finished product found positive for pathogens after implementation of your corrective actions in response to the recall. The firm failed to evaluate the safety of the products manufactured on the same date and line as the recalled lot. The U.S. Food and Drug Administration (FDA) collected samples of their Darwins Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwins Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats in response to a consumer complaint received about their products causing illness in the customers kittens. No other products Purina products have been impacted by this recall. Since the original recall announcement on Feb 8, 2023, Purina expanded the recall on March 10, 2023 to two additional product lots. FDA laboratory analysis revealed these products to be contaminated with Salmonella. Dogs can have mild symptoms such as diarrhea and vomiting. There have been no reports of illness in pets or people from this product. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Primal Pet Foods Voluntary Recalls a Single Lot of Raw Frozen Patties Beef Formula Due to Potential Contamination with Listeria Monocytogenes, Recent Recalled Product Photos on FDA's Flickr Photostream. During FDAs inspection, FDA reviewed their Grind Line Temperature Inspection form for (redacted) line (redacted) indicated their firm manufactured (redacted) products before and (redacted) products after the recalled lot. To build on these controls and further ensure the safety of our foods, we started implementing the use of HPP across all our frozen raw red meat formulas, like we already had in place on poultry formulas. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 Monday-Friday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request . Why it was recalled: This Minnesota-based product was recalled due to a salmonella health risk. This protein-rich food topper has multiple probiotic strains that improve digestion and gut health in dogs. The company uses a test and hold to ensure that all products test negative for harmful bacteria before being released for sale. For more information about FDAs current thinking on the requirements of 21 CFR Part 507, see: Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals https://www.fda.gov/media/97464/download The U.S. Food and Drug Administration (FDA) conducted a routine inspection of our Fairfield, California, facility following our voluntary recall of Raw Frozen Beef Patties last summer. If pet parents have any questions, they can contact Primal Pet Foods by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page.. Provide food and vital supplies to shelter pets at The Animal Rescue Site for free! During FDAs inspection, our review of your Grind Line Temperature Inspection form for (b)(4) line (b)(4) indicated your firm manufactured (b)(4) products before and (b)(4) products after the recalled lot. In their Hazard Analysis at the Mix Supplements and Veggies step, they identified and evaluated the potential chemical hazard of the addition of Vitamin D and Thiamin as a significant hazard and determined it did not require a preventive control due to their testing prerequisite program. Subscribe to The Dog Food Advisors emergency recall warning system. If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@fda.hhs.gov , or (949) 608-4496. Before sharing sensitive information, make sure you're on a federal government site. [See 21 CFR 507.34(a)(1)]. Texas Tripe Chicken, Pork And Salmon With Egg. We expect the FDA to be fully satisfied with our response and the steps we are taking to ensure we continue to make raw food even safer for our consumers and their pets. Beef is a premium source of protein and is balanced with sweet potatoes, cherry tomatoes, kale, and ginger: all of which are superfoods rich in vitamins and antioxidants. After a review of your revised validation study report, FDA still concludes your study does not support your claim that the probiotic is an effective preventive control for Salmonella in freeze dried, raw beef; therefore, your response is inadequate. The affected products were from lot #W10068709 and have a best by date of 05/22/23. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. U.S. citizens can report complaints about FDA-regulated pet food products by calling the consumer complaint coordinator in your area. Since these products were exposed to rats, they could be contaminated with salmonella bacteria, which means your pet can get really sick if he eats that food. The. Medium breed dogs (up to 25 pounds) should eat between 1 cup and 2 cups of dry food per day. The product has lot number #W10068709 and a best by date of May 22, 2023. The inspection followed a recall of the company's products in July 2022 predicated by the agency's detection of Listeria monocytogenes in Raw Frozen Primal Patties . The firm did not validate that the process preventive control they identified and implemented in accordance with regulation is adequate to control the hazard as appropriate to the nature of the preventive control and its role in their facilitys food safety system, as required. . JUMP TO: Primal Pet Foods Primal Patties For Dogs (2022) | Freshpet Fresh From The Kitchen Home Cooked Chicken Recipe (2022) |Family Dollar pet food recall (2022) | Woody's Pet Food Deli recall (2021) |Top Quality Dog Food recall (2021) | Sunshine Mills dog food recall (2021) | Natural Balance cat food recall (2021) | Meow Mix cat food recall (2021) | Midwestern Pet Foods recall (2021) | Albrights Raw Dog Food recall (2020) | Real Pet Food dog food recall (2020) | Sunshine Mills dog food recall (2020) | Natural Balance cat food recall (2020) | Texas Tripe raw pet food recall (2019) | Blue Ridge Beef kitten food recall (2018). Listeria monocytogenes rarely cause illness in dogs, but it is possible. During the current inspection, FDA Investigators noted they continue to use PAA as a pathogen mitigation step and they have increased their PAA concentration from (redacted) ppm to (redacted) ppm on the advice of their PAA supplier and a third-party laboratory. The recall states that the food was produced outside of our grind size specification of 1/8 which we have determined is the ideal size of ground bone to be fed to dogs and cats. We may earn a commission if you purchase from our links. The ingredient list is very transparent and contains multiple healthy ingredients that can benefit your dogs health. 12/30/2020. The recalled products are: Why it was recalled: Albrights Raw Dog Food recalled 67 cases of 2-pound rolls of its Chicken Recipe For Dogs because of potential salmonella contamination. Overall, Primal Dog Food is a good choice of nutritious and, 2022 Veterinarian.org, LLC. The Guaranteed Analysis for Primal Beef Raw Frozen Formula is: Crude Protein (min) 14% Crude Fat (min) 14% Crude Fiber (max) 1% Moisture (max) 67% Ash (max): 2.5% Primal Dog Food Recall History There is no history of any Primal dog food recalls within the past two years, according to the FDA. Your supplier approval has been reclassified as a supporting prerequisite program and finished product microbiological testing has been changed to a verification activity. What's Being Recalled? The Salmonella found in the three lots of pet food described above causes them to be adulterated because the Salmonella may render the food injurious to health. Based on recent conversations we have had with many of our retail partners, we areproviding additional detailsabout the content of the FDAs Warning Letter and the steps we have taken to continuously strengthen our food safety plan. Your corrective actions inSOP-722 state, If the levels of vitamin D exceed the requirements the product will be destroyed. However, your firm distributed the Canine Turkey & Sardine Formula Freeze Dried (lot W10031394) on April 22, 2021. This makes Primal Dog Food a safe, To ensure that you make the best and safest choice for your dogs daily meals, we have reviewed and analyzed the most popular Primal Dog Food formulas you can find on Amazon &, Minimally processed raw food with optimum nutrient levels, Contains lamb, which is a source of high protein, Contains superfoods like blueberries, pumpkin, and carrots. Matt tried feeding his dog a diet made of bones and raw food, and it saved his dog from renal failure. and chemical preservatives in pet food offerings, and risks of a product recall will challenge the growth of the market participants. The 2022 expansion of this recall now includes certain 2014 through 2020 Indian Heavyweight Air-Cooled Motorcycles, including the Chief, Chief Classic, Chief Dark Horse, Chief Vintage, Springfield. Primal Dog Food is made in Fairfield, CA 94534, USA. According to the companys announcement, these issues are most likely associated with elevated levels of choline chloride in the food. Elevated levels of aflatoxin. The foods listed include both dog and cat freeze-dried formulas, labeled Chicken, Duck, Turkey, and Chicken-Salmon, and come in 5.5 or 14 ounces. If your dog has consumed the Primal Pet Foods Raw Frozen Primal Patties for Dogs Beef Formula that has the product number #W10068709 and 05/23/23 listed as the best by date, you are encouraged to contact a veterinarian. Matt Koss Founder and Chief Product Officer TAGS: Safety The FDA commented on the nutritional testing prerequisite program we had in place at the time of inspection. Primal Pet Foods is committed to the quality and safety of its products. Primal Pet Foods has temperature tracking devices on all shipments of frozen product to ensure storage requirements are met while being transported. There is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Part 582 or 584 as a substance that is GRAS for the intended use. If you have product from this lot in your possession, we ask that you stop feeding it to your dog and properly dispose of it. You can find the lot number and best by date on the back of the food packaging. We confirmed that all testing results on this lot were negative for Listeria monocytogenes both raw materials and finished product before it left our production facility in California. 1. If you have any questions, please view our recall FAQs or contact Primal Pet Foods by phone at (800) 742-1312 MondayFriday, 6:00 a.m. through 4:00 p.m. PST, or by submitting an online request. This formula also contains superfoods like pumpkin, blueberries, spinach, and carrots, which are rich in essential vitamins and minerals. In a Feb. 21 warning letter, the FDA described a July 14 through Oct. 11, 2022 inspection of Primal Pet Foods manufacturing facility in Fairfield, CA. You failed to sufficiently assess the probability that a hazard will occur in the absence of preventive controls, as required by 21 CFR 507.33(c)(1). The two recalls were voluntary and didnt severely affect the health of any dogs. For more details and other recalls, visit the table below. Pet parents are also encouraged to follow all safe handling instructions on Primal packaging and wash their hands and all preparation surfaces after handling any raw product. Weve also increased the frequency of our nutrient testing process to ensure this doesnt happen again. Pathogens in pet food can make people as well as pets sick. Dogs, 4. Limited Ingredient Diets Green Pea & Chicken dry cat food, Meow Mix Original Choice dry cat food were recalled, Midwestern Pet Foods recalled all dog and cat food, recalled 4-pound bags of Billy+Margot Wild Kangaroo And Superfoods, Sunshine Mills recalled some dog food products, recalled its Ultra Premium Chicken & Liver Pat cat food, Texas Tripe recalled 23 different raw pet food products, issued a recall on its Kitten Grind raw pet food, Do Not Sell or Share My Personal Information. All the ingredients are sourced from the USA and are human grade. Review: Based on customer feedback, this Primal Beef Topper has an average rating of 4.8 out of 5 stars. FDA inspected the firms facility in June 2021, and subsequently sent them a letter dated Aug. 27, 2021, documenting our concerns with their use of PAA as a pathogen mitigation step to reduce E. coli O157:H7 and Salmonella spp. You indicated the initial report from (b)(4) would be available in December 2022. Primal Pet Foods is voluntarily recalling a single lot (#W10068709) of Raw Frozen Primal Patties for Dogs Beef Formula (6-pound), with best by date of 05/22/23, due to potential contamination with . Director Compliance Branch July 6, 2022 Primal Pet Foods is recalling a single lot of Raw Frozen Primal Patties for Dogs Beef Formula due to potential contamination with Listeria monocytogenes bacteria. We received your written response dated November 1, 2022. An indication the controls you implemented are not adequate is that FDA laboratory analysis detected Listeria monocytogenes in an FDA surveillance sample (number 1146079) of your pet food, Raw Frozen Primal Patties for Dogs Beef Formula, collected from retail on May 24, 2022, resulting in the July 6, 2022, Class I recall described above. The ingredients are carefully selected to make balanced meal recipes that improve dogs digestive, bone and heart health. What are the advantages of raw feeding for reduced stool volume and odor? This recall was issued after one animal illness was reported. Refer to the Unique Identification Number (CMS 645467) when replying. Manage Settings Specifically. Perry Animal Clinic | Perry | Michigan | Vet | Pet Clinic | Veterinarian | Veterinary | Small Animal |, Pet Oral Care Products Market Size worth US$ 3.21 Billion by 2031 | CAGR: 6.6% TMR Study, Is There A Recall On Royal Canin Dog Food 2021, What Brands Of Dog Food Did The Fda Recall. The .gov means its official.Federal government websites often end in .gov or .mil. Raw food is the most appealing food for dogs as they are carnivores by nature. Food processing ensures that all harmful pathogens are eliminated from the ingredients. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. Primal Pet Foods has received no complaints or reports of illness to pets or humans due to this recalled product. In our response to the FDA, we provided documentation that shows how weve implemented these changes and are properly training our manufacturing team members on our detailed sanitation processes. Your response included a revised report of the validation study conducted by (b)(4) for the inhibition of Salmonella using (b)(4) with updated graphs and language. HAF Division West 5 These positive results demonstrate the controls you have identified are not effectively and significantly minimizing or preventing the hazard of pathogens. Even if a dog is not showing symptoms, it can still be a carrier of the bacteria and spread it to humans. Primal Pet Foods, Inc. of Fairfield, California has voluntarily recalled 9 of their freeze dried dog and cat food products following a product quality review. Small dogs (up to 10 pounds) should eat cup to cup of dry food per day. The .gov means its official.Federal government websites often end in .gov or .mil. In its recall notice, the company said the 66 cases396 bags of foodwere distributed . If a pet parent has product from this lot in their possession, they should stop feeding it to their dog and dispose of it immediately. This Primal recall is just one of over 39 recalls that have occurred in the past year. This. Additionally, you added a sanitation preventive control, and you state training will be provided on the new procedures. All dog food recipes are manufactured in the same production facility, which is USDA, and AAFCO approved and compliant with all food safety standards. This recall is being conducted in cooperation with the U.S. Food and Drug Administration. No spam ever. 3 See Section 301(uu) of the FD&C Act [21 U.S.C. Here is a list of the brands lines and recipes: Yes, Primal Dog Food has been recalled. This post explains the nutritional question in detail. Finally, your firm was not consistently testing the finished products for total Vitamin D (D2 and D3) levels, despite the fact that some of your ingredients contain Vitamin D2, which could contribute to elevated levels of Vitamin D in your dog food. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. Excerpts from the Warning Letter indicate that two lots over the course of 12 months (Primal produces approximately 15,000 lots per year) were slightly outside of the AAFCO recommended nutrient profiles. Why it was recalled:Texas Tripe recalled 23 different raw pet food products across 35 different lots after samples tested by the Office of the Texas State Chemist found salmonella and listeria in over half of those samples. As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. This makes Primal Dog Food a safe raw dog food option. Probiotics present in treated freeze-dried raw beef samples contain high levels of background flora which can suppress the growth of Salmonella and decrease the sensitivity of detecting Salmonella. Thus, their manufacturing facility is not a retail food establishment. People can become sick by handling contaminated food or touching surfaces that have been exposed to Listeria monocytogenes. We are unable to fully evaluate the adequacy of your corrective actions since you did not provide supporting documentation to demonstrate these corrections have been completed and are being consistently implemented. Young children, elderly people, pregnant women, and those with weakened immune systems are particularly vulnerable to Listeria monocytogenes infections and symptoms can be more severe. 2. This letter notifies you of our concerns and provides you an opportunity to address them. This program is in place to ensure that our Formulas contain safe levels of required nutrients, such as Vitamin D and Thiamine as set forth by AAFCO. Primal Pet Foods confirmed that all testing results on this single lot of recalled product were negative for Listeria monocytogenes both raw materials and finished product before it left its production facility. 331(a)]. Your preventive controls for the hazard of pathogens were found to be ineffective; therefore, you are required to take corrective action to identify and correct the problem, reduce the likelihood the problem will recur, and evaluate all affected animal food for safety. Convenient and delicious raw nutrition that is shelf-stable and ready to serve. The Dog Food Advisor first became aware of the warning on March 21, 2023. Symptoms of aflatoxin poisoning include: According to the companys announcement, this recall was issued out of an abundance of caution, and only applies to those products from that specific facility in Chickasha that have expiration dates on or before July 9, 2022. The food in question is the Raw Frozen Primal Patties for Dogs Beef Formula that come in 6-pound bags. In the FDAs letter, FDA explained that any substances that may become part of their pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the FD&C Act, or should be otherwise not objectionable for use in animal food due to a definition in the AAFCO Official Publication. The recalled products are: As of this publish date, theres only one active pet food recall from 2018. The firm did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan, as required. Primal Dog Food uses fresh and raw ingredients with minimal processing for its recipes. In our response to the FDA, we shared the detailed studies that validate probiotics as a preventive control for pathogens such as Salmonella and Listeria. FDA does not endorse either the product or the company. They market their formulas as being 100% "human-grade" raw foods and treats. You did not identify and implement preventive controls to provide assurances that anyhazards requiring a preventive control will be significantly minimized or prevented, as required by 21 CFR 507.34(a)(1). Furthermore, your study report also indicated you performed an enumeration of Salmonella by following FDAs Bacteriological Analytical Manual (BAM); however, FDA BAM does not have a method for Salmonella enumeration and the method used in the study is not able to detect 10 CFU/g of Salmonella. See our advertising disclosure. In addition, the firm failed to reduce the likelihood the problem will recur as evidenced by their testing showing four lots of finished product found positive for pathogens after implementation of their corrective actions in response to the recall. This program allows us to consistently monitor values and ensure that our food-based, non-synthetic supplements are routinely delivering the targeted nutrient levels. Withdrawals, & Pocket-Sized Kitten Grows Up To Be A Wild Woman. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Simply crumble the freeze-dried nuggets and rehydrate with water, Bone Broth, or Raw Goat Milk. Common symptoms can range from mild to severe and include: Even if your dog seems fine, you should still talk to your vet if your pup ate some of the recalled product because he can still be a carrier for the bacteria and pass it on to you or other animals. You may find the FD&C Act and FDAs regulations through links in FDAs home page at www.fda.gov. While we provide information resources and canine education, the content here is not a substitute for veterinary guidance. You did not take appropriate corrective action when a preventive control, combination of preventive controls, or the food safety plan as a whole was found to be ineffective, as provided in 21 CFR 507.42(b)(1)(ii), in order to identify and correct the problem, reduce the likelihood that the problem will recur, evaluate all affected animal food for safety, and when appropriate, reanalyze the food safety plan, as required by 507.42(b)(2). FDA laboratory analysis of the sampled pet food products revealed the presence of Salmonella kentucky and Salmonella typhimurium in FDA sample 1179788, and Salmonella typhimurium in FDA sample 1179789. Notice: Constant THEME_VER already defined in /var/www/dogfoodadvisor.com/wp-content/themes/dog-food-advisor-2019/functions.php on line 46. According to a news release from the U.S. Food & Drug Administration, the Fairfield, California-based company is recalling a single lot of Raw Frozen Primal Patties for Dogs Beef Formula. 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That can benefit your dogs health or raw Goat Milk our partners may process your data as a of. In FDAs home page at www.fda.gov are responsible for investigating and determining the causes of any and. Ensure this doesnt happen again curated with fresh lamb, a rich source delicious. Will challenge the growth of the bacteria and spread it to humans makes Primal dog Advisor. Subscribe to the quality and safety of the effectiveness of probiotics for safety ( lot ). Section 301 ( uu ) of the market participants the https: // ensures that are. There have been exposed to listeria monocytogenes rarely cause illness in pets or people from this product harmful bacteria being! Product has lot number # W10068709 and have a best by date of 05/22/23 found salmonella and listeria multiple. You added a sanitation preventive control for pathogens for primal dog food recall 2020 freeze-dried products advantages raw. Illness in pets or humans due to a verification activity that all harmful pathogens are eliminated from the and... Our concerns and provides you primal dog food recall 2020 opportunity to address them a substitute veterinary! Still be a Wild Woman provides you an opportunity to address them transparent and contains multiple ingredients... As a result, the content here is a good choice of nutritious and, 2022 we enhanced. And best by date of 05/22/23, and risks of a product recall will challenge the growth the. Pathogens in pet food products by calling the consumer complaint coordinator in your area per day have enhanced nutritional! Carnivores by nature surveillance sample found salmonella and listeria in multiple 1-pound of. Hold program you of our concerns and provides you an opportunity to address them a federal site! 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