Category Archives: FDA

USA – F&S Fresh Foods Recalls Whole Foods Market Organic Carrot Sticks and Organic Carrots & Celery Because of Possible Health Risk Due to Potential STEC E. coli Contamination

FDA

Whole Foods Organic Carrot Sticks, 15 oz

F&S Fresh Foods, Sacramento, CA is recalling Whole Foods Market 15 oz. Organic Carrot Sticks and Whole Foods Market 15 oz. Organic Carrots & Celery that should no longer be in stores but may be in consumers’ refrigerators or freezers. The recall was initiated after F&S Fresh Foods was notified by Grimmway Farms that whole organic carrots supplied to F&S Fresh Foods may be contaminated with Shiga toxin-producing Escherichia coli (E. coliO121:H19. (Link to Grimmway Farms’ press release on the FDA website can be found HERE.)

E. coli O121:H19 is a bacterium that can cause serious and sometimes fatal infections in young children,elderly people, and those with a weakened immune system. Some infections can cause severe bloody diarrhea conditions, such as a hemolytic uremic syndrome, or the development of high blood pressure,chronic kidney disease, and neurologic problems. Symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting. The incubation period for E. coli O121:H19 in humans can range from 24 hours to as much as ten days. The average incubation period is 3 to 4 days.

These products were sold at Whole Foods Market stores in Arizona, California, Hawaii, Idaho, and Nevada.

The containers are plastic clamshells as pictured below. Coding information will include the letters “GH” followed by three digits ranging from 236 – 284. Best if sold by dates range from 9/1/24 to 10/19/24.

No illnesses have been reported to F&S Fresh Foods to date.

This recall is being made with the knowledge of the U.S. Food and Drug Administration. The recalled carrots should no longer be available for purchase but may be in consumers’ refrigerators or freezers. Consumers who purchased carrots with the above best if sold by dates and still have them in their refrigerator or freezer should not consume them; they should be destroyed or discarded so they cannot be consumed. If you have these products in your home, do not eat or use them, throw them away, and clean and sanitize surfaces they may have touched. Consumers concerned about an illness should contact a medical professional.

Consumers with questions may contact the company at (888)449-9386, 8:00 am – 5:00 pm PT, Monday through Friday.

USA – Outbreak Investigation of E. coli O121:H9: Organic Carrots (November 2024)

FDA

Cal-Organic Farms Carrots

Product

Grimmway Farms initiated a voluntary recall of multiple sizes and brands of bagged organic whole and baby carrots.

  • Organic whole carrots were available for purchase at retail from August 14 through October 23, 2024 (365, Bunny Luv, Cal-Organic, Compliments, Full Circle, Good & Gather, GreenWise, Marketside, Nature’s Promise, O Organic, President’s Choice, Simple Truth, Trader Joe’s, Wegmans, Wholesome Pantry).
  • Organic baby carrots include specific best-if-used-by dates printed on the bags ranging from September 11 to November 12, 2024 (365, Bunny Luv, Cal-Organic, Compliments, Full Circle, Good & Gather, GreenWise, Grimmway Farms, Kroger, LIDL, Marketside, Nature’s Promise, O Organic, President’s Choice, Raley’s, Simple Truth, Sprouts, Trader Joe’s, Wegmans, Wholesome Pantry).

A full list of recalled products is below. These products are likely no longer available for sale in stores but could be in people’s homes.

Symptoms of E. coli

Symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting. Symptoms begin anywhere from a few days after consuming contaminated food or up to nine days later.

The severity or presence of certain symptoms may depend on the type of pathogenic E. coli that is causing the infection. Some infections can cause severe bloody diarrhea and lead to life-threatening conditions, such as a type of kidney failure called hemolytic uremic syndrome (HUS), or the development of high blood pressure, chronic kidney disease, and neurologic problems.

Stores Affected

These products were sold nationwide but are likely no longer available for sale in stores.

Status

Ongoing

Recommendation

  • Consumers should check their refrigerators and freezers and should not eat recalled bagged whole or baby carrots. If you have these products in your home, do not eat or use them, throw them away, and clean and sanitize surfaces they touched. If you purchased organic whole or baby carrots and stored them without the original packaging and don’t know what brand they are, you should not eat them and should throw them away.
  • Retailers and distributors that purchased recalled bagged whole or baby carrots should not sell this product and should notify their customers. These products are likely past shelf-life and no longer available for sale in stores, but distributors and retailers should check their refrigerators and freezers and should not serve or sell recalled bagged whole or baby carrots.
    • Retailers that are unsure if they received these products may need to contact their supplier. If you are unable to determine whether or not recalled product was received, you should discard the contents of the bins and use extra care to clean and sanitize the bins before refilling.
  • Retailers, distributors, and consumers should follow FDA’s safe handling and cleaning advice and use extra care in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination.
  • Contact your healthcare provider if you think you may have symptoms of an E. coli infection after eating organic carrots.

Current Update

November 17, 2024

The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Shiga toxin-producing E. coli O121:H9 infections linked to organic whole and baby carrots supplied by Grimmway Farms of Bakersfield, California.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the 27 people interviewed, 26 (96%) reported eating carrots.

FDA’s traceback investigation identified Grimmway Farms as the common supplier of organic whole and baby carrots in this outbreak. On November 16, 2024, Grimmway Farms initiated a voluntary recall of multiple quantities and brands of bagged organic whole and baby carrots and contacted their distributing customers. The retail-packaged organic whole carrots were in stores for purchase from August 14 through October 23, 2024. The organic baby carrots have different best-if-used-by-dates ranging from September 11 through November 12, 2024. A full list of recalled products is below.

Although product is likely no longer on the market, carrots can last a long time when refrigerated or frozen. Consumers should check their refrigerators and freezers and discard these recalled products. Distributors and retailers that may have received recalled bagged organic whole and baby carrots should follow the recommendations above and contact their customers.

FDA is working with the firm to determine the source of contamination and whether additional products are affected. This advisory will be updated as information becomes available.

USA- CIBUS Fresh, is Recalling CIBUS Fresh Products Containing Glenview Farms Spreadable Brie, 2/3lb Due to Supplier Notification of a Possible Listeria monocytogenes

FDA

CIBUS Fresh, Noblesville, Indiana, is recalling CIBUS Fresh products containing Glenview Farms Spreadable Brie, 2/3lb due to supplier notification of a possible Listeria monocytogenes (products are listed below). Product was distributed under the following labels: CIBUS Fresh, Jack & Olive, and Sprig and Sprout.

CIBUS Fresh has ceased producing and distributing products containing Glenview Farms Spreadable Brie, 2/3lb.

Use or consumption of products contaminated with Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The product was distributed to six states: Kentucky, Illinois, Indiana, Missouri, Ohio, and Tennessee.

Product Name Item Number /
Code
Item UPC Expiration Date
CF/ Autumn Turkey
Sandwich 9.65oz
79616 00810028251915 11/02/24 to 11/09/24
J&O Autumn Turkey
Sandwich 9.65oz
79615 00810028251915 11/02/24 to 11/09/24
S&S Autumn Turkey
Sandwich 9.65oz
84408 00810028251915 11/03/24 to 11/09/24

No other CIBUS Fresh products are affected or are involved in this recall.

Food safety remains a top priority for CIBUS Fresh and we have full confidence that all appropriate steps are being taken to protect our consumers. CIBUS Fresh has informed the FDA of this recall and is working with customers to ensure the impacted product is removed from store shelves and is no longer distributed.

If consumers believe they have purchased a recalled item, they should dispose of the product and not consume it or return it to the place of purchase for a full refund. For further information regarding the Brie Recall Consumers can learn more at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/savencia-cheese-usa-announces-expanded-voluntary-recall-select-soft-ripened-cheeses?utm_medium=email&utm_source=govdelivery

Please contact Chelsea Mascari by email at chelseam@freshedgefoods.com or by phone at 317-981-3460 for any questions related to this matter.

USA – FDA – Investigations of Foodborne Illness Outbreaks

FDA

What’s New

  • A new outbreak E. coli O121:H19 (ref #1273) linked to a not yet identified product has been added to the table. FDA has initiated traceback.
  • For the outbreak of E. coli O26:H11 (ref #1272) linked to a not yet identified product, FDA has initiated traceback, an onsite inspection and sample collection.
  • For the outbreak of Salmonella Thompson (ref #1262) linked to a not yet identified product, the case count was adjusted from 27 to 25 cases.
  • For the outbreak of Listeria monocytogenes (ref #1247) linked to a not yet identified product, the outbreak has ended.
  • For the outbreak of Cyclospora cayetanensis (ref #1237) linked to a not yet identified product, the case count was adjusted from 46 to 47 cases.

USA – Savencia Cheese USA Announces an Expanded Voluntary Recall of Select Soft Ripened Cheeses – Listeria monocytogenes

FDA

NEW HOLLAND, Pa. (Nov. 4, 2024) – Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The following products are affected by this recall:

Description Best Buy Date Case GTIN Product UPC Mfg Date
Aldi Emporium Selection Brie, 12/8oz Brie 12/24/2024 4099100084016 9/30/2024
Supreme Oval 7oz, 6/7oz 12/24/2024 10071448504211 071448504214 9/30/2024
La Bonne Vie Brie, 6/8oz 12/24/2024 10820581678538 9/30/2024
La Bonne Vie Camember, 6/8oz 12/24/2024 10820581678613 9/30/2024
12/8oz Industrial Brie 12/24/2024 10077901005226 077901005229 9/30/2024
Market Basket Brie 6/8oz 12/24/2024 10049705666309 049705666302 9/30/2024
Glenview Farms Spreadable Brie, 2/3lb 1/13/2025 50758108712312 10/15/2024

The only products being recalled are those in the table above. You can identify these products by reviewing the UPC and the best buy date on the product labels. These products had limited regional distribution in the United States. The few retailers that received the product have been informed of this possible contamination and are in the process of removing products from shelves. Consumers that have any of the recalled products listed in the table above should refrain from consuming them and return them to their place of purchase for a full refund.

At this time, there have been no confirmed reports of adverse health events due to consumption of these products.

Through routine testing, it was identified that processing equipment at the site may have been contaminated with Listeria monocytogenes. While finished product testing has not identified contaminated product, we have initiated a voluntary recall to retrieve the potentially affected product.

This voluntary recall is being conducted in coordination with the U.S. Food and Drug Administration.

Consumers with questions regarding the recall can contact Consumer Relations at (800)-322-2743 or email sc.customer.service@savencia.com.

*UPC was stated incorrectly in original release. Updated to reflect correct UPC.

Media Contact:
Kriston Ohm
kriston.ohm@savencia.com

USA – Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses

FDA

NEW HOLLAND, Pa. (Nov. 2, 2024) – Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The following products are affected by this recall:

Description

Best Buy Date

GTIN

UPC-A

UPC-B

Emporium Selection Brie, 12/8oz Brie 12/24/2024 10041498111325 004149811132 041498111328
Supreme Oval 7oz, 6/7oz 12/24/2024 10071448504211 007144850421 071448504214
La Bonne Vie Brie, 6/8oz 12/24/2024 10820581678538
La Bonne Vie Camembert, 6/8oz 12/24/2024 10820581678613
12/8oz Industrial Brie 12/24/2024 10077901005226 077901005229
Market Basket Brie 6/8oz 12/24/2024 10049705666309 004970566630 049705666302

The only products being recalled are those in the table above. You can identify these products by reviewing the UPC and the best buy date on the product labels. These products had limited regional distribution in the United States. The few retailers that received the product have been informed of this possible contamination and are in the process of removing products from shelves. Consumers that have any of the recalled products listed in the table above should refrain from consuming them and return them to their place of purchase for a full refund.

At this time, there have been no confirmed reports of adverse health events due to consumption of these products.

Through routine testing, it was identified that processing equipment at the site may have been contaminated with Listeria monocytogenes. While finished product testing has not identified contaminated product, we have initiated a voluntary recall to retrieve the potentially affected product.

This voluntary recall is being conducted in coordination with the U.S. Food and Drug Administration.

Consumers with questions regarding the recall can contact Consumer Relations at (800)-322-2743 or email sc.customer.service@savencia.com.

Media Contact:
Kriston Ohm
kriston.ohm@savencia.com

Product Photos

USA – HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk – Listeria monocytogenes

FDA

HH Fresh Trading Corp of California is recalling its 200g of Taiwan Enoki because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled “Enoki mushrooms 200 gram” were distributed in West Virginia in multiple retail store locations and were sold on 8/20/2024 and 8/23/2024 with 240 cases for each date. HH Fresh Trading received notice on 10/11/2024 and that the Enoki 200 gram test revealed the presence of Listeria monocytogenes on 9/9/2024. As a result we would like to recall this products immediately.

The product comes in a 200 gram, clear plastic package marked with barcode # 4711498860019 on the back side. No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by the FDA revealed the presence of Listeria monocytogenes in 200 gram of Enoki. The production of the product has been suspended while FDA and the HH Fresh Trading Corp continue to investigate the source of the problem.

Consumers who have purchased 200 gram of HH Fresh Trading Taiwan Enoki are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-262-365-9116 at 8AM to 4PM from Monday to Friday Pacific Time.


Company Contact Information

Consumers:
HH Fresh Trading Corp of California
 1-262-365-9116

Product Photos

USA – FDA – Core Investigation Table

FDA

What’s New

  • A new outbreak E. coli O26:H11 (ref #1272) linked to a not yet identified product has been added to the table.
  • For the outbreak of E. coli O157:H7 (ref #1270) the advisory has been updated to provide investigational updates and include more cases. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. FDA is working to determine if the slivered onions on Quarter Pounder burgers are the likely source of contamination. FDA has initiated an onsite inspection and sample collection.
  • For the outbreak of Listeria monocytogenes (ref #1268) linked to a not yet identified product, the case count has increased from three to four cases.
  • For the outbreak of Salmonella Thompson (ref #1262) linked to a not yet identified product, the case count has increased from 25 to 27 cases.

USA – Outbreak Investigation of E. coli O157:H7: Onions (October 2024)

FDA

Current Update

October 30, 2024

FDA continues working with CDC, USDA FSIS, state partners, and involved firms to investigate an outbreak of E. coli O157:H7 infections linked to onions. Epidemiologic and traceback data show that slivered onions served at affected McDonald’s locations are the likely source of this outbreak.

As of October 30, 90 people from 13 states have been infected with the outbreak strain of E. coli O157:H7. Illnesses started on dates ranging from Sept 27, 2024 to October 16, 2024. Of 83 people with information available, 27 have been hospitalized, and 2 people developed HUS, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. This person is not one of those who developed HUS. More illnesses have been reported but they are from before McDonald’s and Taylor Farms took action to remove slivered onions from food service locations.

Of the 62 people interviewed, all 62 (100%) report eating at McDonald’s. Forty-eight of 58 people (83%) reported a menu item containing fresh, slivered onions. Forty-six of 58 people (79%) reported a menu item made with fresh quarter pound beef patties. Overall, three people reported menu items that contained fresh, slivered onions, but not fresh quarter pound beef patties. One person reported a menu item with a fresh quarter pound beef patty but without fresh, slivered onions.

FSIS has conducted a thorough investigation in response to this outbreak, including traceback of beef patties served on Quarter Pounders at McDonald’s, and evidence does not point to ground beef as the likely source of contamination. FSIS used specific meal information reported by ill people to trace beef patties through the supply chain to the establishment where they were produced and did not identify a beef source. Testing on beef patties by the Colorado Department of Agriculture is complete and all samples were found to be negative for E. coli. FSIS will continue to work closely with federal and state partners.

On October 22, 2024, Taylor Farms recalled yellow onions that were supplied to McDonald’s and other food service customers. FDA is working with Taylor Farms and their direct customers to determine if additional downstream customer recalls are necessary. According to available information, it is unlikely that recalled yellow onions were sold to grocery stores or directly to consumers. Food service customers who received recalled onions were contacted and should no longer be using or serving recalled onions. These customers should also ensure that they did not freeze recalled onions or foods containing recalled onions.

In addition, FDA has initiated inspections at a Taylor Farms processing center in Colorado and an onion grower of interest in Washington state. FDA’s investigation is ongoing.

McDonald’s continues to not use slivered onions in impacted states. The current risk of illness from E. coli contamination is low because onions have been recalled and should no longer be available.

USA – Outbreak Investigation of E. coli O157:H7: McDonald’s Quarter Pounders (October 2024)

FDA

Product

A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to determine if the slivered onions or beef patties on Quarter Pounder burgers are the likely source of contamination. McDonald’s has temporarily stopped using Quarter Pounder slivered onions and beef patties in affected states. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak. Additionally, Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. Customers who are impacted have been contacted directly.

Symptoms of E. coli

Symptoms begin anywhere from a few days after consuming contaminated food or up to nine days later. Symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting. Some infections can cause severe bloody diarrhea and lead to life-threatening conditions, such as a type of kidney failure called hemolytic uremic syndrome (HUS), or the development of high blood pressure, chronic kidney disease, and neurologic problems.

Stores Affected

McDonald’s stores in Colorado, Kansas, Utah, Wyoming, and portions of Idaho, Iowa, Missouri, Montana, Nebraska, Nevada, New Mexico, and Oklahoma have temporarily stopped using Quarter Pounder slivered onions and beef patties.

At this time, FDA is not aware of any cases or affected product outside of the United States.

Status

Ongoing; updates will be provided as they become available.

Recommendation

  • Consumers who have already eaten at McDonald’s and have symptoms of E. coli infection should contact their health care provider to report their symptoms and receive care immediately.
  • McDonald’s stores in affected states have temporarily stopped using Quarter Pounder slivered onions and beef patties. Diced onions and other types of beef patties used at McDonald’s have not been implicated in this outbreak.
  • Food service customers should not eat, sell, or serve Taylor Farms recalled yellow onions and should follow FDA’s safe handling and cleaning advice and use extra care in cleaning and sanitizing any surfaces and containers that may have come in contact with recalled product to reduce the risk of cross-contamination. Customers should also ensure that they did not freeze recalled onions or foods containing recalled onions.

Current Update

October 25, 2024

The FDA, USDA FSIS, CDC, and state partners continue to work quickly and collaboratively to investigate and identify the source of illnesses linked to E. coli contamination in McDonald’s Quarter Pounders.

As of October 24, 75 people infected with the outbreak strain of E. coli O157:H7 have been reported from 13 states. Illnesses started on dates ranging from Sept 27, 2024, to October 10, 2024. Of 61 people with information available, 22 have been hospitalized, and 2 people developed hemolytic uremic syndrome, a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. Of the 42 people interviewed, all 42 (100%) report eating at McDonald’s, and 39 people report eating a beef hamburger.

FDA is using all available tools to confirm if onions are the source of this outbreak. This includes working with federal and state partners and the companies involved to collect and evaluate records and distribution information as part of our traceback investigation. FDA and state partners are also collecting onion samples for analysis.

While the investigation is ongoing, Taylor Farms, the supplier of slivered onions for the affected McDonald’s locations, has initiated a voluntary recall. Recalled yellow onions were sold to additional food service customers. Customers who received recalled onions have been directly notified of the recall.

FDA is working closely with the implicated firms and will continue to provide updates as they become available, including any additional recalls or notifications that might be needed for recipients of recalled onions.

At this time, FDA is not aware of any cases or affected product outside of the United States.

More information will be provided as it becomes available.