Category Archives: FDA

USA – Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts – STEC E.coli

FDA

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Organic Romaine Hearts (UPC 7-11535-50201-2), with Harvested-On dates of 10-23-20 and 10-26-20.  The recall is being conducted due to a possible health risk from E. coli in the two products.  Dole Fresh Vegetables is coordinating closely with regulatory officials. No illnesses have been reported to date in association with the recall.

Pathogenic E. coli can cause diarrhea, severe stomach cramps and vomiting.  Most people recover within a week, but some illnesses can last longer and can be more severe.

The Harvested-On sticker is located on the upper right corner of each bag and the UPC code is located on the bottom right corner of the back of each bag. The Dole package contains three organic romaine hearts and the Wild Harvest product is packaged in a 12oz bag. The impacted products were distributed in AZ, HI, IA, IL, IN, KS, MD, MI, MN, MO, MS, MT, NC, ND and VA. These products were harvested and packed nearly 4 weeks ago and should no longer be in commerce.  Consumers are advised to check product they have in their homes and discard any product matching the production description, UPC codes and Harvested-On dates listed above.

This precautionary recall notification is being issued due to an isolated instance in which a package of Dole™ Organic Romaine Hearts – 3pk yielded a positive result for pathogenic non-O157 E.coli STEC in a routine sample collected at a retail store by the Michigan Department of Agriculture and Rural Development. There is no indication at this time that this positive result is related to any illnesses nor consumer complaints and it is not associated with the strains connected to the ongoing outbreaks currently under regulatory investigation.

No other Dole products are included in the recall. This voluntary recall does not apply to any bagged or clamshell salad romaine product. Only the specific Organic Romaine Hearts listed, with the exact UPC codes and Harvested-On dates identified above, are included in the recall. Consumers who have any remaining product with these UPC codes and Harvested-On dates should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Consumer Center at 1-800-356-3111, which is open 24 hours a day.


Company Contact Information

Consumers:
Consumer Center
 1-800-356-3111
Media:
William Goldfield
 1-818-874-4853
 William.Goldfield@Dole.com

Product Photos

USA – FDA – Investigations of Foodborne Illness Outbreaks

FDA

The following is a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.

public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

USA – Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)

FDA

The FDA and CDC, in collaboration with state and local partners, is investigating illnesses in a third multistate outbreak of E.coli O157:H7 infections this Fall.

On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.

The strain of E. coli found in the Michigan sample is a third distinct strain not genetically related to the strains causing two distinct multi-state outbreaks of Shiga-toxin producing E. coli O157:H7 (STEC) that FDA and CDC announced on October 28, 2020. At this time, a specific food has not been linked to either of those outbreaks.

On November 6, 2020, Tanimura & Antle, Inc. recalled packaged single head romaine lettuce with a pack date of 10/15/2020 or 10/16/2020 due to possible contamination with E. coli O157:H7. The firm recalled this product based on test results from a product sample collected and analyzed by MDARD before the WGS analysis showing the match to the outbreak strain was completed.

FDA and state partners are working with the firm to determine if additional romaine should be recalled.

At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.

Recommendation

Consumers, restaurants, and retailers, should not eat, sell, or serve Tanimura & Antle, Inc. brand packaged single head romaine lettuce with a pack date of 10/15/2020 or 10/16/2020.

USA – Fresh Express Inc – Div of Chiquita Brands – FDA Warning Letter

FDA

The U.S. Food and Drug Administration (FDA ) inspected your bagged salad operation located at 1109 East Lake Street, Streamwood, IL 60107, from June 25, 2020 through July 23, 2020. The inspection was initiated as part of an investigation of a multistate foodborne outbreak of cyclosporiasis (human infections with the parasite Cyclospora cayetanensis). As of September 23, 2020, the Centers for Disease Control and Prevention (CDC) reported that at least 701 people from 14 states have been infected with Cyclospora cayetanensis. Based on epidemiological and traceback evidence, CDC and FDA have determined that bagged salad mixes containing iceberg lettuce, carrots, and red cabbage manufactured at your Streamwood, IL facility were the source of this multistate cyclosporiasis outbreak. On June 19, 2020, you recalled bagged salad mix containing iceberg lettuce, red cabbage, and carrots, because they had the potential to be contaminated with Cyclospora. The Public Health Agency of Canada is also investigating an outbreak of cyclosporiasis infections occurring in three Canadian provinces in which Fresh Express brand salad products containing iceberg lettuce, carrots, and red cabbage have been identified as the likely source of the outbreak. This is the second outbreak of cyclosporiasis linked to Fresh Express product. In 2018, a multistate foodborne outbreak of cyclosporiasis involving 511 confirmed cases from 15 states was linked to salads sold at a fast food restaurant and manufactured at your Streamwood, IL facility.

USA – Outbreak Investigation of Salmonella Stanley: Wood Ear Mushrooms – Dried Fungus (September 2020)

FDA

The FDA, along with CDC and state and local partners, investigated a multistate outbreak of Salmonella Stanley infections linked to wood ear mushrooms imported by Wismettac Asian Foods, Inc. of Santa Fe Springs, CA. Wood ear mushrooms are a dried mushroom, also commonly labelled or referred to as Kikurage, Dried Black Fungus, Dried Fungus, or Mu’er/Mu Er/Mu-Err.

Wismettac Asian Foods, Inc. acted quickly upon being notified of the positive test result and recalled all wood ear mushrooms within shelf life on September 23, 2020.

Recommendation

Wood ear mushrooms imported by Wismettac Asian Foods, Inc. were only sold to restaurants and were not available directly to consumers. Although these items have been recalled, restaurants that received recalled products should use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with the recalled product, to reduce the risk of cross contamination. All recalled product should be thrown out.


Investigation Update

November 4, 2020

As of November 4, 2020, the CDC declared that this outbreak is over.

General Food Safety Tips for Dried Mushrooms

Dried mushrooms, that have not been recalled due to potential contamination, should always be reconstituted using boiling water to kill any pathogens. This advice does not apply to recalled products, which should be thrown out.

Product Images

Outbreak Investigation of Salmonella Stanley in Wood Ear Mushrooms (September 2020) - Photos of Recalled Shirakiku Dried Fungus

Recall Information

On September 23, 2020, Wismettac Asian Foods, Inc. recalled Shirakiku brand imported dried fungus. This product was labeled as Shirakiku brand Black Fungus (Kikurage) with UPC Code 00074410604305, imported from China. Product was distributed in six packs of five-pound bags to restaurants in AR, CA, CO, CT, DE, DC, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NV, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.

USA – Sunshine Mills, Inc. Expands Previously Announced Voluntary Recall of Certain Pet Food Products Due to Potentially Elevated Levels of Aflatoxin

FDA

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Food & Beverages
Pet Food
Ingredients
Reason for Announcement:
May Contain Aflatoxin
Company Name:
Sunshine Mills, Inc.
Brand Name:
Champ, Field Trial, Good Dog, and Others
Product Description:
Pet Food

Company Announcement

Sunshine Mills, Inc. is expanding its voluntary recall of certain pet food products that were made with corn that contained Aflatoxin at levels above FDA’s action levels. This is an expansion of the recall initiated September 2, 2020, after an investigation conducted along with the U.S. Food and Drug Administration determined that additional corn-based pet food products produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin. 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. 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.

Sunshine Mills, Inc. has chosen to expand its voluntary recall to include these additional products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. Pets with aflatoxin toxicity (aflatoxicosis) may show symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, diarrhea, and in some cases, death. Pets experiencing any of these symptoms after consuming the recalled products should be seen by a veterinarian.

The affected products were distributed in retail stores within the United States. Principle Super Premium Natural Dog Food is exported exclusively to a distributor in Japan. Sportsman’s Pride Maintenance Adult Formula Dog Food is also exported to a distributor in Japan and Colombia. Retailers who received the recalled lots have been contacted and asked to pull any remaining inventory of these lots from their shelves. There are no other Champ®, Field Trial®, Good Dog, Hunter’s Special®, Old Glory®, Paws Happy Life®, Pet Expert, Principle, Retriever®, River Bend, Sportsman’s Pride®, Sprout®, Thrifty®, Top Runner® or Whiskers & Tails products or other lot codes of these products affected by this voluntary recall. The lot codes can be located on the back of each bag.

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.

The expansion of this voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

USA – Meijer Recalls Whole Cantaloupes and Select Cut Cantaloupe Trays Due to Potential Health Risk – Salmonella

FDA

Meijer, in conjunction with Eagle Produce, LLC in Aguila, AZ., is announcing a voluntary recall of whole cantaloupe and select cut cantaloupe fruit trays and bowls. The recall is part of a sampling investigation by the Michigan Department of Agriculture and Rural Development and is due to the potential risk of Salmonella.

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 multi-state recall involves whole cantaloupe and select cut cantaloupe fruit trays and bowls in various weights ranging from 6–40 ounces sold between Sept. 26 and Oct. 5 of this year at all Meijer stores in Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin. There have been no illnesses reported to date.

The recalled whole cantaloupe would have a sticker label stating Kandy Brand from Eagle Produce, LLC. If there is no sticker label to identify it, then it should be considered part of the recall. In addition, Meijer may have used cantaloupe ingredients that originated from Eagle Produce, LLC in the store made products. The following packaged products are in clear plastic containers under the Meijer brand label include:

9450 – Gas Station Mixed Melon Chunk Cup
9505 – Gas Station Mixed Fruit Cup
9644 –  Gas Station Cantaloupe  6 oz
21921000000 – Fruit Frenzy Bowl 40 oz
21921400000 – Fruit Tray
21924800000 – Fruit Tray with Dip
21932300000 – Cantaloupe Chunks Large PLU 4960
21933400000 – Mixed Melon Chunks Large Bowl
21933700000 – Mixed Melon Chunks Small Bowl
21960100000 – Fruit Frenzy 16 oz Bowl PLU
21971100000 – Strawberry/Pineapple Cup 6 oz
21971200000 – Mixed Fruit Cup 6 oz
21971700000 – Berry Explosion Cup 6 oz
21971800000 – Mixed Melon Chunk Cup 6 oz
21984400000 – Mixed Melon Cup
22012400000 – Mixed Fruit Cup
22019600000 – Cantaloupe Chunks Small Bowl
22020000000 – Fruit Frenzy 32 oz Bowl PLU 1
22021900000 – Cantaloupe and Honeydew Slices
22022000000 – Mixed Melon Slices
22045000000 – Fruit Palooza
22045200000 – Melons & Berries
22045300000 – Triple Treat & Melon
22061600000 – Cantaloupe Chunks Large Kosher
22061700000 – Cantaloupe Chunks Large Kosher
28873400000 – Fruit Salad

Consumers who have purchased this product should throw it away or return the product to the nearest Meijer store for a full refund. Consumers with questions regarding this recall should contact Meijer at 800-543-3704, available 24 hours a day, seven days a week. Consumers with questions or concerns about their health should contact their physician.

About Meijer: Meijer is a Grand Rapids, Mich.-based retailer that operates 253 supercenters throughout Michigan, Ohio, Indiana, Illinois, Kentucky and Wisconsin. A privately-owned and family-operated company since 1934, Meijer pioneered the “one-stop shopping” concept and has evolved through the years to include expanded fresh produce and meat departments, as well as pharmacies, comprehensive apparel departments, garden centers and electronics offerings. For more information on Meijer, please visit www.meijer.comExternal Link Disclaimer.External Link Disclaimer Follow Meijer on Twitter @twitter.com/MeijerExternal Link Disclaimerand @twitter.com/MeijerPRExternal Link Disclaimeror become a fan at www.facebook.com/meijerExternal Link Disclaimer.External Link Disclaimer


Company Contact Information

Consumers:
Meijer
 800-543-3704
Media:
Joe Hirschmugl
 616-791-3943
 Joseph.Hirschmugl@Meijer.com

Product Photos

USA – Outbreak Investigation of Salmonella Newport: Red Onions (July 2020)

FDA

The FDA, along with CDC and Canadian, state, and local partners, has been investigating a multistate outbreak of Salmonella Newport infections. FDA’s traceback portion of the investigation is complete and has identified Thomson International, Inc. of Bakersfield, CA, as the likely source of potentially contaminated red onions.

The multistate outbreak of Salmonella Newport infections linked to red onions from Thomson International, Inc. that were sold in several regions of the United States and Canada, investigated by the FDA, along with CDC and Canadian, state, and local partners, is over. The outbreak resulted in recalls for multiple onion varieties and products containing onions. FDA’s traceback investigation identified a packing facility and multiple farms that supplied red onions during the time period of interest. Joint FDA, California Department of Public Health (CDPH), and California Department of Food and Agriculture (CDFA) field-level investigations were initiated at multiple Thomson International Inc. locations and surrounding areas within days of identifying the suspect vehicle and the firm. However, most product had already been harvested and distributed by that time. Thus far, FDA has completed over 2000 product and environmental analyses from multiple Thomson International Inc. locations and surrounding areas, including water, soil, and scat samples. Although a variety of genetic strains of Salmonella Newport have been detected, as well as multiple other Salmonella serotypes, a genetic match to the outbreak strain has yet to be identified in any of the samples collected. Additional sample analysis is underway.  Although the outbreak is being declared over, the FDA will continue its root cause investigation and will communicate any findings that could assist future prevention efforts.

Recommendations

According to the CDC, this outbreak appears to be over. Recalled products should no longer be available in stores, but onions have a long shelf-life and recalled products could still be in consumer’s homes or in restaurants, especially if recalled products were frozen.

Advice for consumers, restaurants, and retailers: Consumers, restaurants, and retailers should not eat, sell, or serve recalled onions from Thomson International, Inc. or products containing recalled onions. If you cannot tell if your onion is part of the recall, or your food product contains recalled onions, you should not eat, sell, or serve it, and should throw it out.

FDA recommends that anyone who received or suspects having received recalled onions, or products containing recalled onions, use extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with recalled products to reduce the risk of cross-contamination. This includes cutting boards, slicers, countertops, refrigerators, and storage bins.

Consumers who have symptoms of Salmonella infection should contact their health care provider. Most people with salmonellosis develop diarrhea, fever, and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases may become fatal.

Suppliers and Distributors: Suppliers, distributors and others in the supply chain should not use, ship or sell recalled onions from Thomson International, Inc. or food products containing recalled onions. Suppliers and distributors that re-package raw onions should use extra vigilance in cleaning any surfaces and storage areas that may have come into contact with recalled onions. If there has been potential cross contamination or mixing of onions from other sources with recalled onions, suppliers and distributors should discard all comingled and potentially cross-contaminated product.

Investigation Update

October 8 Update

According to the CDC, this outbreak appears to be over. Recalled products should no longer be available in stores, but onions have a long shelf-life and recalled products could still be in consumer’s homes or in restaurants, especially if recalled products were frozen.

Although the outbreak is being declared over, the FDA will continue its root cause investigation and will communicate any findings that could assist future prevention efforts.

USA – Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin

FDA

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

 


Company Contact Information

Consumers:
Sunshine Mills, Inc. Customer Service
 (800) 705-2111
 customer.service@sunshinemills.com

Product Photos

USA – Russ Davis Wholesale Recalls Peaches and Peach Salsa Because of Possible Health Risk

FDA

Russ Davis Wholesale (RDW) is recalling Peach Salsa under the Crazy Fresh and Quick & Easy brands in an abundance of caution due to possible contamination with Salmonella.

Salmonella may 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.

This recall is in response to Wawona Packaging initiating a recall of peaches early in the day August 22, 2020 as an ingredient provider to Russ Davis Wholesale.

To date, Russ Davis Wholesale has not received any reported illnesses related to this organism.

The affected products are:

UPC Product Name Brand Name on Label Packaging Image SELL BY Date
795631 820270 Crazy Fresh Perfectly Peach Salsa Crazy Fresh Perfectly Peach Salsa 8 oz. See below 6/25/2020 to 8/26/2020
795631 820270 Quick & Easy Perfectly Peach Salsa Quick & Easy Perfectly Peach Salsa 8 oz. See below 7/29/2020 to 8/26/2020
795631 820270 Clear Label Perfectly Peach Salsa Clear Label Perfectly Peach Salsa 8 oz. See below 7/30/2020 to 8/23/2020

Affected product was delivered to retail stores in Minnesota, Wisconsin, North Dakota, South Dakota, Michigan, Iowa, Nebraska, and Wyoming.

Some containers of peach salsa may have been purchased from the deli counter at grocery stores located in Ortonville, MN, Cross Lake, MN and Tipton, IA.

Five Bountiful Fresh gift baskets, also containing the recalled peaches were sold through one location in Hastings, MN.

Retailers have been instructed to remove affected products from store shelves and destroy.

Consumers are urged to immediately throw any product they may have away and not consume.

Consumers with questions may contact the company at: customerservice@russdaviswholesale.com or 877-433-2173 between 8:00 am and 5:00pm central standard time.

About Russ Davis Wholesale

Russ Davis Wholesale www.russdaviswholesale.comExternal Link Disclaimer, is a leading processor, wholesaler and distributor of fresh produce, supplying fresh and wholesome conventional and organic fruits and vegetables to retail, wholesale and food service customers throughout the Midwest. Our Crazy Fresh branded foods www.crazyfreshproduce.comExternal Link Disclaimer are guaranteed fresh-cut and ready-to-eat, offering convenient, healthy choices the whole family can enjoy any time of day.

Outbreak Posting


Company Contact Information

Consumers:
Russ Davis Wholesale
 877-433-2173
 customerservice@russdaviswholesale.com
Media:
Courtney Willis
 612-281-3361
 cwillis@russdaviswholesale.com

Product Photos