Category Archives: Food Safety and Inspection Service

Primal Pet Foods Voluntarily Recalls A Single Lot of Raw Frozen Cat Food

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300-PrimalPrimal Pet Foods is voluntarily recalling a single batch production code of Feline Turkey Raw Frozen Formula 3-pound bag. FDA tested product in response to a single consumer complaint. Primal Pet Foods was alerted by FDA that the testing of two bags of this lot resulted in a low thiamine level. Neither FDA nor Primal have received any other reports concerning Thiamine in Primal products. No other product manufactured by Primal Pet Foods is involved in this voluntary recall.

Cats fed only diets low in thiamine for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting, and weight loss. In advanced cases, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. If your cat has consumed the recalled lot and has these symptoms, please contact your veterinarian. If treated promptly, thiamine deficiency is typically reversible.

Only the product with the following Best By date and production code is included in the voluntary recall. It is best to check the production code on the back of the bag to determine if the product has been recalled or not.

The lot involved in this voluntary recall is:

Primal Pet Foods Feline Turkey Raw Frozen Formula 3-pound bag (UPC# 8 50334-00414 0) with Best By date 060815 B22

Primal takes very seriously, the need for adequate Thiamine levels in our feline diets. We include Organic Quinoa Sprout Powder as a natural B-Complex supplement to ensure that adequate levels of Thiamine are met. Additionally, Thiamine occurs naturally in other ingredients contained in our Feline Turkey Formula such as: Turkey Muscle Meat (including heart), Turkey Liver, Organic Sunflower Seeds, Dried Organic Kelp, Organic Collard Greens and Organic Squash.

Consumers who still have bags of cat food from this lot should stop feeding it to their cats and call us at (866) 566-4652 Monday through Friday, 9:00 am – 4:00 pm PST. Consumers with further questions should visit our website at www.primalpetfoods.com or call us at this same number.

Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Sundried Tomato, Spinach Pesto, and Chipotle Wraps

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El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.

El Popocatepetl’s 8in. Flavored Wraps were distributed in the state of Illinois, primarily in the Chicago area.

The information on how the recalled products can be identified is listed below:

Product Name: 8in. Sundried Tomato
Brand Name: El Popocatepetl
Description: 8in. Tomato Flavored Wrap
UPC: 0 20784 99505 7
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Spinach Pest
Brand Name: El Popocatepetl
Description: 8in. Spinach Flavored Wrap
UPC: 0 20784 58314 8
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Chipotle
Brand Name: El Popocatepetl
Description: 8in. Chipotle Flavored Wrap
UPC: 0 20784 78248 0
Any Product with the Best By Date of
April 1, 2015 and Before.

The recall was initiated during a review of the product ingredients and the labeled ingredients revealed milk and Yellow #5 was present in an ingredient used to make the flavored wraps but not listed as ingredients on the labels. No Illnesses have been reported to date.

All recalled products are being removed from the store shelves. No other El Popocatepetl products are involved in this recall.

Consumers who have purchased the recalled product can return it to the place of purchase for a full refund. Consumers with questions may contact the Company Consumer Department at 773-843-0888.

Hummingbird Wholesale Issues Allergy Alert on Undeclared Milk in Organic Chocolate Hazelnut Butter

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hummingbird-1WASHINGTON — Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an allergy or severe sensitivity to milk products run the risk of serious or life threatening allergic reaction if they consume this product.

No illnesses have been reported to date.

The recalled product sold to retail outlets in California, Oregon, and Washington and directly to consumers in Oregon in 1 pound (454 gram) glass jars that show lot number of 15023 on a white sticker on the jar between the dates of 1/27/15 and 2/19/15.

HW Item # Lot # UPC Code
N270 15023 6-96859-11035-1

The recall was initiated after it was discovered that a supplier had changed the ingredients without notice to include milk in the 65% dark chocolate used to make the Organic Chocolate Hazelnut Butter. The label does not show milk as an ingredient. Only lot # 15023 was made with the affected chocolate.

Consumers who purchased this product are welcome to return it to the place of purchase for a full refund, or to contact Hummingbird at 541-686-0921 ext. 105 from 8am to 4pm PST Monday through Friday.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Hummingbird Wholesale has taken immediate action to recall the affected Organic Chocolate Hazelnut Butter in order to ensure the safety of its consumers.

Hummingbird Wholesale is dedicated to providing the highest quality organic and raw products, and the safety of our customers is our number one priority.

ESS Food Recalls Pork Products Produced Without Benefit of Import Inspection

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USDA-RECALL-1WASHINGTON – ESS Food, a Danish establishment, is recalling approximately 50,904 pounds of pork belly product produced in Poland that was not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless pork belly was produced on various dates from March 3, 2014 to April 11, 2014. The following product is subject to recall:

Approximately 40-lb. boxes containing 4-5 pieces of “PINI POLONA PORK BELLY BONELESS”

The products subject to recall bear the establishment number “10023802” inside the Polish mark of inspection. The products were shipped to a distributor in Texas and a processing facility in Iowa.

The problem was discovered during routine surveillance of storage facilities when an FSIS investigator observed that the products lacked USDA import inspection marks.

This is a Class I Recall which indicates a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Consumers or Media with questions about the recall can contact Michael Stentebjerg, Area Manager, at (404) 254-8510.

Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements

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dextrol-recallDetox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.

Product Name Bottle Color Label # Capsules UPC Lot Expiration
EDGE Amplified Weight Release White Purple label 60 852175004174 ALL
iNDiGO White Dark blue label 60 852175004044 000034 4/10/2017
AMPD Gold Bee Pollen White Black label 60 852175004181 ALL
BtRim Max White Dark Red label 60 852175004068 00002 4/27/2017
iNSANE Bee Pollen White Bright Red label 60 852175004082 0000:02 6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Fluoxetine is an SSRI with potentially life-threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores. No illnesses have been reported to date with the use of these products.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

See’s Candies, Inc. Issues alert on Red Heart with Assorted Chocolates

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ucm433410SAN FRANCISCO — See’s Company of San Francisco is recalling all 8 oz Classic Red Hearts with Assorted Chocolates with bar code 737666091201 and stamped date L.A.N. 048/15 because it contains undeclared tree nuts. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, coconut) run the risk of serious or life-threatening allergic reaction if they consume these products.

Product was distributed nationwide through See’s Candies Retail Stores and Mail Order (Web/Phone/Catalog). The product is sold packaged at the stores in 8oz Red Heart boxes. No illnesses have been reported to date. The product UPC is: 737666091201.ucm433411

The recall was initiated after a retail store discovered a red heart with the incorrectly labeled base mixed in with properly labeled bases.

Consumers who have purchased Sees’ Candies Classic Red Hearts with Assorted Chocolates with bar code 737666091201 and lot L.A.N.048/15 and are sensitive to tree nuts are urged to return the hearts to the place of purchase for a full refund or exchange. Consumers with questions may contact the company at 1-800-789-7337 (Monday thru Friday, 8:30am to 4:30pm PDT).

Tarrier Foods Issues Allergy Alert on Undeclared Peanuts and Egg in Chopped Twix

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twixColumbus, OH – Tarrier Foods of Columbus, OH is recalling 316 cases of Chopped Twix item 0807, because it may contain undeclared peanuts and eggs. People who have an allergy or severe sensitivity to peanuts and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.

The Chopped Twix product was distributed to wholesale warehouses in Michigan, Minnesota, North Dakota, and Florida where it was distributed to foodservices.

The product can be identified by the item number 0870 on the outside of the case. The inside contains two bags in white film marked “CHOPPED TWIX Lot 087034314.”

No illnesses have been reported to date.

The recall was initiated after it was discovered that product containing peanuts and eggs was distributed in packaging that did not reveal the presence of peanuts and egg on the ingredient statement. Subsequent investigations are being performed to determine the temporary breakdown in the company’s production and packaging processes.”

Consumers who have purchased Chopped Twix lot code 080734314 are urged to return it to the distributor for a full refund. Consumers with questions may contact Tarrier Food’s Customer Service at (614) 876-8595.

Nebraska Firm Recalls Pork Belly Product Produced Without Import Inspection

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WASHINGTON – Quality Meats, Inc., an Omaha, Neb., establishment, is recalling approximately 44,372 pounds of frozen pork belly product because they were not presented at the border for USDA-FSIS Import Inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. This is a Class I recall since the benefit of full inspection, a possibility of adverse health consequences exists.

Product subject to recall includes:

  1. Various weight cases of “rosderra IRISH MEATS Swine Pork Belly”

The Frozen Pork Single Ribbed Bellies product was packaged March 18, 2014 through April 10, 2014. The product subject to recall bears the Ireland establishment number “IE 356 EC.” This product was shipped to retail establishments and distributors in Georgia, Illinois, and Washington where the products would have been repackaged.

The problem was discovered during a routine review using the Automated Commercial Environment (ACE) database. ACE is a web-based portal for the collection and use of international trade data maintained by U.S. Customs and Border Protection.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for imported product when the product is not presented for inspection at the U.S. border.

A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.

B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product

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B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products.  There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.

This recall affects the following products:

Consumer UPC # Size Best By Date Range Description
0 39000 00805 1 10oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00818 1 16.7oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00820 4 1.25 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning
0 39000 00821 1 3.75 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning  (3 Pack)
0 39000 00860 0 5 lb. Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00861 7 9 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00890 7 8 oz Feb 18, 2017  –  Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 00891 4 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 39000 01012 2 15.2oz May 18, 2015 – Feb 10, 2016 Ortega Soft Taco Dinner Kit
0 39000 01892 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 39000 01893 7 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 01894 4 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 41501 00806 5 9.15oz May 18, 2015 – Feb 10, 2016 Ortega Whole Grain Taco Kit
0 41501 00824 9 1.25oz Feb 18, 2016-Nov 3, 2016 Ortega 40% Less Sodium Taco Seasoning
0 41501 00832 4 5oz May 18, 2015 – Feb 10, 2016 Ortega “Tacos for Two” Kit
0 41501 00882 9 144 g 15 MA 18- 16 FE 10 Ortega “Tacos for Two” Kit (Canada)
0 41501 00897 3 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Green Taco Sauce – Mild
0 41501 00898 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Enchilada Sauce
0 41501 00907 9 16 oz Feb 18, 2017-Nov 10, 2017 Ortega Green Taco Sauce  –  Mild
0 41501 01014 3 13.6 oz May 18, 2015-Feb 10, 2016 Ortega Whole Wheat Soft Taco Kit
0 41501 01015 0 21.3oz May 18, 2015 – Feb 10, 2016 Ortega Grande Hard & Soft Taco Dinner Kit
0 41501 01058 7 15.9oz May 18, 2015-Feb 10, 2016 Ortega Whole Grain/Whole Wheat  Hard & Soft Taco Kit
0 41501 01895 8 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 41501 08351 2 9.8oz May 18, 2015 – Feb 10, 2016 Ortega Fiesta Flats Kit
0 41501 79811 9 3.75 oz Feb 18, 2016-Nov 3, 2016 Las Palmas Taco Seasoning Packet (3 Pack)
0 41501 79812 6 106 g 16 FE 18 –  16 NO 03 Las Palmas Taco Seasoning Packets (3 Pack) (Canada)
0 41501 79890 4 8 oz Feb 18, 2017-Nov 10, 2017 Las Palmas Taco Sauce (Mild)
0 41501 79990 1 226g 17 FE 18 – 17 NO 10 Las Palmas Taco Sauce (Mild) (Canada)
N/A .33 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Sauce Packets (Foodservice)

The recalled products were distributed in retail stores and foodservice outlets nationwide.

This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled.  For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled.  This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.

“The safety of our consumers is our number one priority.  We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods.  “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”

This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.

Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.

Texas Firm Recalls Boudin Products Due To Possible Temperature Abuse

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FSIS Photo


WASHINGTON – Carlton Foods, a New Braunfels, Texas establishment, is recalling approximately 25,764 pounds of fresh Boudin products, which were produced with pre-cooked rice that may have experienced temperature abuse and may contain an emetic toxin produced by Bacillus cereus, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The Boudin (sausage-like) products were produced on Aug. 22, 2014, through Oct. 17, 2014. The following products are subject to recall:

  • 12-oz. vacuum-packed packages of “RICHARD’S HICKORY SMOKED BOUDIN”
  • 12-oz. vacuum-packed packages of “RICHARD’S PREMIUM BOUDIN”
  • 12-oz. vacuum-packed packages of “RICHARD’S ‘HOT’ PREMIUM BOUDIN”
  • 16-oz. vacuum-packed packages of “RICHARD’S PREMIUM BOUDIN”
  • 32-oz. vacuum-packed packages of “RICHARD’S CAJUN GRILLERS BOUDIN”

The products subject to recall bear the establishment number “EST. 1943” or “EST. 961” inside the USDA mark of inspection. Products with the EST. 961 inside the mark of inspection would also have NB printed on the label. “Sell By” dates for the recalled products range from Oct. 28, 2014, to Dec. 16, 2014. The products were shipped to retail locations in Louisiana and Texas.

The problem was discovered by FSIS personnel during a Food Safety Assessment. During production, FSIS personnel observed pre-cooked rice, a component of the Boudin, being held at unsafe temperatures which could result in the products containing an emetic toxin produced by Bacillus cereus.

Bacillus cereus is a type of bacteria that can be found in a variety of foods, particularly rice that has been stored too long at room temperature. Emetic toxins produced by Bacillus cereus are characterized by nausea and vomiting occurring within 30 minutes to six hours after consumption of contaminated foods.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Individuals concerned about an illness should contact a health care provider.