FDA/USDA ~ September & updates for August ~ Alerts & Safety ~ 2020


  • Wismettac Asian Foods, Inc., Santa Fe Springs, CA is issuing a voluntary recall for Shirakiku brand imported Dried Fungus (also known as Black Fungus or Kikurage) because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.The product was distributed to restaurants in Arkansas, California, Colorado, Connecticut, Delaware, Washington DC, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and British Columbia in Canada.
    • Affected Product:
    Item Number Item Description Pack Size UPC Code Product Lot Code Package Photo
    #60403 BLACK FUNGUS (KIKURAGE) 5LB 5 LB 00074410604035 All Lots with Item #60403 on the package See below

    Wismettac is initiating the recall after the California Department of Public Health discovered the presence of Salmonella in the product. The manufactuer has been made aware of the issue, and is conducting an investigation to determine the cause of the issue so corrections can be implemented.

    To ensure consumer safety, all distribution of the affected product has ceased and restaurant customers have been notified for the product removal.

    Consumers with questions may contact the company at recall@wismettacusa.com.

  • 023-2020, Cher-Make Sausage Company Recalls Fully Cooked Meat Sausage Products Due to Misbranding and an Undeclared Allergen (Sep 11, 2020)
  • RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. RLC Labs, Inc. has not received any reports of adverse events related to this recall.Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles.To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the below documents. These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies.RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ).
  • Sunshine Mills, Inc. is issuing a voluntary recall of certain dog food products due to levels of Aflatoxin that are potentially above the acceptable limit.  Aflatoxin is a naturally occurring mold by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities.The potential for aflatoxin levels above the acceptable limit in these products was discovered by routine sampling performed by the Louisiana Department of Agriculture and Forestry showing that a sample of a single 4-pound bag of one lot of the product contained elevated levels of aflatoxin.  No illnesses have been reported in association with these products to date, and no other Sunshine Mills, Inc. pet food products are affected by this announcement.While no adverse health effects related to these products have been reported, Sunshine Mills, Inc. has chosen to issue a voluntary recall of these products as a precautionary measure in furtherance of its commitment to the safety and quality of its products.  Pets that have consumed any of the recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian.The affected products were distributed in retail stores nationally.  Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves.  There are no other Family Pet®, Heartland Farms®, or Paws Happy Life® products or other lot codes of these products affected by this precautionary recall.Consumers who have purchased the recalled products should discontinue use of the product and may return the unused portion to the place of purchase for a full refund. Consumers may contact Sunshine Mills, Inc. Customer Service at (800) 705-2111 from 7AM to 4PM Central Time, Monday through Friday, or by email at customer.service@sunshinemills.com for additional information.This is a voluntary recall being conducted in cooperation with the U.S. Food and Drug Administration.Products affected by this announcement:

    Product Name

    Size

    Lot Codes

    UPC Code

    FAMILY PET® MEATY CUTS BEEF CHICKEN & CHEESE FLAVORS PREMIUM DOG FOOD 4 lb. TD3 4/APRIL/2020
    TD1 5/APRIL/2020
    3225120694
    14 lb. TB1 4/APRIL/2020
    TB2 4/APRIL/2020
    TB3 3/APRIL/2020
    3225118078
    28 lb. TB3 3/APRIL/2020 3225120694
    HEARTLAND FARMS® GRILLED FAVORITES
    BEEF CHICKEN & CHEESE FLAVOR
    14 lb. TB1 4/APRIL/2020
    TB2 4/APRIL/2020
    7015514299
    31 lb. TA2 4/APRIL/2020
    TA3 4/APRIL/2020
    7015514301
    PAWS HAPPY LIFE® BUTCHER’S CHOICE DOG FOOD 16 lb. TA1 4/APRIL/2020
    TA2 4/APRIL/2020
    3680035763
  • Aug. 18, 2020 – Faribault Foods Inc., a Faribault, Minn. establishment, is recalling approximately 15,134 pounds of canned soup product due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk and soy, known allergens, as well as beef and pork, which are not declared on the product label.

The cans labeled as chicken noodle soup actually contain a meatball and pasta product. The canned soup items were produced on May 26, 2020. The following products are subject to recall: [View Labels (PDF only)]

  • 14-oz. cans of “PROGRESSO ORGANIC CHICKEN NOODLE SOUP” with a best by date of “BestByMAY262022” printed on the bottom of the can and a best by date of “09JUN2022” printed on the product case.

The products subject to recall bear establishment number “EST18826A” printed on the bottom of the can under the best by date. These items were shipped to retail locations nationwide.

The problem was discovered when the firm’s distributor notified FSIS of consumer complaints that the soup contained meatballs and pasta instead of chicken and noodles.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in consumers’ pantries. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Members of the media with questions about the recall can contact the General Mills Media Help Line at 763-764-6364 or Media.line@genmills.com. Consumers with questions about the recall can contact the General Mills Consumer Help Line at 1-800-200-9377.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

USDA Recall Classifications
Class I This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
Class II This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.
Class III This is a situation where the use of the product will not cause adverse health consequences.