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  1. Outbreaks of Foodborne Illness

Outbreak Investigation of Cyclospora: Bagged Salads (June 2020)

CDC reports additional cases. FDA finds Cyclospora in irrigation canal.

The FDA, along with CDC and state and local partners continue to investigate a multistate outbreak of Cyclospora infections potentially linked to salad products that were made by Fresh Express containing iceberg lettuce, red cabbage, and carrots and that were sold in several regions of the United States. The investigation includes Fresh Express branded products as well as products made by Fresh Express for retail store brands sold at ALDI, Giant Eagle, Hy-Vee, Jewel-Osco, ShopRite, and Walmart.

Recommendations

On June 27, 2020, Fresh Express recalled products containing either iceberg lettuce, red cabbage or carrots and displaying the product code Z178, or a lower number. The “Best by” date on the products run through July 14, 2020.

The recalled products are now well beyond expiration and likely no longer on the market or in consumers’ homes.

Investigation Update

August 14, 2020

FDA’s traceback investigation identified several farms in the U.S. that may have provided product used in the Fresh Express salads that were recalled. FDA investigated multiple farms identified in the traceback. In Florida, FDA analyzed water samples from two public access points along a regional water management canal (C-23), located west of Port St. Lucie, Florida. These samples tested positive for Cyclospora cayetanensis using FDA’s validated testing method. Given the emerging nature of genetic typing methodologies for this parasite, the FDA has been unable to determine if the Cyclospora detected in the canal is a genetic match to the clinical cases, therefore, there is currently not enough evidence to conclusively determine the cause of this outbreak. Nevertheless, the current state of the investigation helps advance what we know about Cyclospora and offers important clues to inform future preventive measures.

FDA is working with the state of Florida and the local water district in the area to try to determine the source and impact of Cyclospora in the canal.

As of August 14, 2020, CDC is reporting a total of 690 cases across 13 states.

FDA’s traceback investigation is complete, however the cause or source of the outbreak has not yet been determined via traceback. Based on the traceback, carrots are no longer being investigated for this outbreak. Two of the salad ingredients, red cabbage and iceberg lettuce, continue to be items of interest in the investigation. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.

Previous Updates


Product Images

Fresh Express Iceberg Red Cabbage and Carrots Bag Use by Date Image

Product Recall

On June 27, 2020, Fresh Express recalled products containing either iceberg lettuce, red cabbage or carrots and displaying the product code Z178, or a lower number. The “Best by” date on the products run through July 14, 2020. These products were either branded with the Fresh Express label, or with a number of retail store brand labels. The recalled retail store brands were ALDI Little Salad Bar, Giant Eagle, Hy-Vee, Jewel-Osco Signature Farms, ShopRite Wholesome Pantry, and Walmart Marketside. 

The recalled products displaying the product code Z178 or lower were sold in Arkansas, Connecticut, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Virginia, Vermont, Wisconsin, West Virginia, and the District of Columbia.

The recalled products were made in the Fresh Express production facility in Streamwood, Illinois and have the potential to be contaminated with Cyclospora. The recent Fresh Express recall also includes previously recalled store brands

See the following press releases for complete details on the recalled products:

Case Count Map Provided by CDC

Outbreak Investigation of Cyclospora Bagged Salads Case Count Map

U.S. Distribution Map of Recalled Bagged Salads

Outbreak Investigation of Cyclospora in Bagged Salads (Distribution Map, June 29 2020)

This map includes confirmed distribution information from companies; products could have been further distributed and sent to additional retailers and states.


Case Counts

Total Illnesses: 690
Hospitalizations: 37
Deaths: 0
Illness Onset Date Range: 5/11/2020 – 7/20/2020
States with Cases: GA (1), IA (206), IL (209), KS (5), MA (1), MN (86), MO (57), NE (55), ND (6), OH (4), PA (2), SD (13), WI (45)


Previous Updates

July 23, 2020

As of July 22, 2020, CDC is reporting a total of 641 cases across 11 states.

FDA’s traceback investigation is ongoing to determine the cause and source of the outbreak. Salad ingredients (iceberg lettuce, carrots, red cabbage) continue to be items of interest in the investigation. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.

July 9, 2020

FDA’s traceback investigation is ongoing to determine the cause and source of the outbreak. Salad ingredients (iceberg lettuce, carrots, red cabbage) continue to be items of interest in the investigation. FDA’s inspection continues at the Fresh Express production facility in Streamwood, Illinois.

As of July 8, 2020, CDC is reporting a total of 509 cases across 8 states.

The Public Health Agency of Canada has issued a public health notice regarding an outbreak of Cyclospora infections in Canada. Exposure to certain Fresh Express brand salad products containing iceberg lettuce, carrots, and red cabbage, has been identified as a likely source of the outbreak. The Public Health Agency of Canada, Canadian Food Inspection Agency, FDA and CDC are collaborating on these ongoing Cyclospora investigations.

FDA continues to work with retailers to ensure the potentially adulterated products are effectively removed from the marketplace. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.

June 29, 2020

Currently, the epidemiologic and traceback information collected by federal and state investigators indicates that a likely cause of this outbreak is product made at the Fresh Express production facility in Streamwood, Illinois. 

FDA has begun an inspection at the Fresh Express production facility in Streamwood, Illinois and has begun a traceback investigation to find the cause and source of the outbreak. FDA has also been working with Fresh Express to identify other retailers it has supplied with products containing iceberg lettuce, red cabbage, or carrots.

Between June 20 and June 25, there were recalls of salad products containing these ingredients.  These recalls included products sold at ALDI, Hy-Vee, Jewel-Osco, and Walmart.

On June 26, 2020, FDA and CDC discussed with Fresh Express concerns that additional products made in the Streamwood facility could also contain Cyclospora. The firm agreed to recall the products of concern. On June 27, 2020, Fresh Express products containing either iceberg lettuce, red cabbage or carrots and displaying the product code Z178, or a lower number. The recalled products were made in the Fresh Express production facility in Streamwood, Illinois and have the potential to be contaminated with Cyclospora.

FDA is continuing to work with retailers to ensure the potentially adulterated products are effectively removed from the market place. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.

June 26, 2020

On June 25, 2020, Fresh Express recalled 12- and 24-ounce bagged Walmart Marketside Classic Iceberg Salad, sold in Walmart stores in Iowa, Minnesota, Michigan, Nebraska, North Dakota, South Dakota, and Wisconsin.

On June 22, 2020, ALDI, in association with Fresh Express Inc., recalled ALDI’s 12-ounce Little Salad Bar Brand Garden Salads from stores in Arkansas, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, North Dakota, South Dakota, and Wisconsin.

On June 20, 2020, Hy-Vee and Jewel-Osco recalled their 12-ounce bagged and labeled “Garden Salad” products. Hy-Vee recalled its 12 oz. Hy-Vee Bagged Garden Salad product on June 20, 2020 across its eight-state region.

On June 20, in a press release, Jewel-Osco stated its recall of bagged Signature Farms Garden Salad, sold in its stores in Illinois, Indiana, and Iowa, was ”in cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections” in midwestern states.

Fresh Express is the manufacturer of each of these recalled salads.

Although the investigation is ongoing, CDC’s analysis of epidemiologic information indicates that bagged salads from ALDI, Hy-Vee, Walmart, and Jewel-Osco grocery stores are a likely cause of the illnesses.

FDA has begun an inspection at the Fresh Express production facility in Streamwood, Illinois, and has concerns that other products made with iceberg lettuce, red cabbage, or carrots may have the potential to be contaminated with Cyclospora.  FDA has discussed these concerns with Fresh Express and the firm has agreed to recall the products of concern.  More information on the recall will be forthcoming from Fresh Express.

FDA has also initiated a traceback investigation to determine supplier and distributor information to find the cause and source of the outbreak.

There may be additional retailers and products impacted by this outbreak. FDA is working with Fresh Express to identify other retailers it has supplied with products containing iceberg lettuce, red cabbage, and carrots.

FDA is continuing to work with retailers to ensure the potentially adulterated products are effectively removed from the market place. As this outbreak investigation continues, the FDA will provide additional updates to this advisory.

June 23, 2020

On June 22, 2020, ALDI, in association with Fresh Express Inc., recalled ALDI’s 12-ounce Little Salad Bar Brand Garden Salads from stores in Arkansas, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, North Dakota, South Dakota, and Wisconsin.

FDA continues this investigation and there may be additional retailers and products impacted by this outbreak.

FDA is working with retailers to ensure the potentially adulterated products are effectively removed from the market place. As this outbreak investigation continues, the FDA will continue to provide additional updates to this advisory.

June 22, 2020

On June 20, 2020, Hy-Vee and Jewel-Osco recalled their 12-ounce bagged and labeled "garden salad" products. Hy-Vee recalled its 12 oz. Hy-Vee Bagged Garden Salad product on June 20, 2020 across its eight-state region. Fresh Express is the manufacturer of these salads.

In a press release, Jewel-Osco stated its recall of bagged Signature Farms Garden Salad, sold in its stores in Illinois, Indiana, and Iowa, was "in cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections" in midwestern states.

ALDI has reported to FDA that they have removed the ALDI Little Salad Bar Brand Garden Salad from store shelves.

FDA is working with the retailers to ensure the potentially adulterated products are effectively removed from the market place. As this outbreak investigation continues, the FDA will provide additional updates to this advisory as more information becomes available.

June 19, 2020

As of June 19, 2020, The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), and state and local partners, are investigating a multistate outbreak of Cyclospora illnesses potentially linked to ALDI Little Salad Bar Brand Garden Salad from ALDI grocery stores, Hy-Vee Brand Garden Salad from Hy-Vee grocery stores, and Signature Farms Brand Garden Salad from Jewel-Osco.

Although the investigation is ongoing, CDC’s analysis of epidemiologic information indicates that these bagged salads from ALDI, Hy-Vee and Jewel-Osco grocery stores are a likely cause of the illnesses. FDA has initiated a traceback investigation to determine supplier and distributor information to find the cause and source of the outbreak.

FDA is in the beginning stages of this investigation and there may be additional retailers and products impacted by this outbreak. As this outbreak investigation continues, the FDA will provide additional updates to this advisory as more information becomes available.


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Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

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