Food

FDA Investigates Multistate Outbreak of E. coli O157:H7 Infections Linked to SoyNut Butter

State Laboratory Tests of SoyNut Butter Samples Confirm Product Contaminated with E. coli

March 21, 2017

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Update: March 21, 2017

The FDA, CDC, and state public health officials continue to investigate an ongoing multistate outbreak of Shiga toxin-producing E. coli O157:H7. The collaborative investigation revealed the E. coli infections are linked to I.M. Healthy SoyNut Butter. To date, 23 people in nine states are infected with the outbreak strains. The most recent illness started on March 5, 2017. Ten people have been hospitalized and seven patients have developed hemolytic uremic syndrome (HUS), a potentially life-threatening type of kidney failure.

On March 2, 2017, several state health departments began to collect open and unopened samples of I.M. Healthy SoyNut Butter from the homes of ill people and from retail locations. Six samples collected by the California Department of Public Health, one sample collected by the Oregon Health Authority, and one sample collected by the Washington Department of Health tested positive and matched the outbreak strains by PFGE.

Update: March 10, 2017

The SoyNut Butter Co. of Glenview, IL has expanded its recall of SoyNut Butter products to include Dixie Diner’s Club brand Carb Not Beanit Butter, in addition to all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products, because the products may be contaminated with Escherichia coli (E. coli) O157:H7 bacteria.

Update: March 7, 2017

The SoyNut Butter Company has recalled all lots of I.M. Healthy SoyNut Butter and I.M. Healthy Granola because they may be contaminated with Shiga toxin-producing Escherichia coli (E. coli) O157:H7 bacteria. All Best By dates of I.M. Healthy SoyNut Butters and I.M. Healthy Granola are included in the recall. I.M. Healthy SoyNut Butter is packaged in 15 oz. plastic jars, individual portion cups, 4 lb. plastic tubs or 45 lb. pails. SoyNut Butter is available in Original Creamy, Chunky, Honey Creamy, Unsweetened and Chocolate. I.M Healthy Granola is packaged in individual serving packages, 12 oz. bags, 50 oz. bags, and 25 lb. bulk bag. I.M. Healthy Granola is available in Original, Apple, Blueberry, and Raisin and Cranberry. The FDA urges consumers not to eat or serve the recalled products.

The CDC has announced they are now investigating 16 illnesses related to this outbreak in nine states. The most recent illness started on February 21, 2017.

The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC), and state and local authorities, have been investigating a multistate outbreak of Shiga toxin-producing Escherichia coli (E. coli) O157:H7 infections. A total of 23 illnesses have been reported from Arizona, California, Maryland, Missouri, New Jersey, Oregon, Virginia, Washington and Wisconsin.

On March 3, 2017, The SoyNut Butter Company voluntarily recalled I.M. Healthy Original Creamy SoyNut Butter with the Best By dates of August 30, 2018, and August 31, 2018

On March 4, 2017, The SoyNut Butter Company expanded its recall of I.M. Healthy Original Creamy SoyNut Butter to include product packaged in 15oz. plastic jars with the Best By dates of July 05, 2018, August 30, 2018, and August 31, 2018; individual portion cups with the Best By date of August 08, 2018; and 4lb. plastic tubs with Best By dates of November 16, 2018 and July 25, 2018.

What is the Problem and What is Being Done About It?  

The FDA and the CDC, along with state and local health officials, are investigating an outbreak of Shiga toxin-producing E. coli O157:H7 infections linked to the consumption of I.M. Healthy brand SoyNut Butter produced by The SoyNut Butter Company of Glenview, IL.

According to the CDC, as of March 21, 2017, a total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from nine states. The number of ill people identified in each state is as follows: Arizona, (4), California (5), Maryland (1), Missouri (1), New Jersey (1), and Oregon (6) Virginia (2), Washington (2) and Wisconsin (1). Ten ill people have been hospitalized, and seven people developed hemolytic uremic syndrome (HUS), a potentially life-threatening type of kidney failure. Twenty of the 23 illnesses were reported in children under the age of 18. No deaths have been reported.

Known illnesses started on dates ranging from January 4, 2017 to March 5, 2017. Ill people range in age from 1 to 48 years, with a median age of 8. The epidemiologic evidence available to investigators indicates that I.M. Healthy SoyNut Butter is a likely source of the outbreak. In interviews conducted by state and local health department officials, ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill. Twenty of the 23 people reached for interviews reported either eating I.M. Healthy brand SoyNut Butter at home in the week before they became ill, attending a facility that served I.M. Helathy SoyNut Butter, or attending childcare centers that served I.M. Healthy SoyNut Butter and the I.M. Healthy granola.

On March 2, 2017, the FDA and CDC held a call with the owners of the SoyNut Butter Company to advise the firm about the multistate outbreak linked to their SoyNut Butter products. The FDA’s investigation of the firm and production methods continues.

CDC recommends that consumers not eat, and childcare centers and other institutions not serve, any variety or size of I.M. Healthy SoyNut Butter or I.M. Healthy granola, or Dixie Diner's Club brand Carb Not Beanit Butter produced by SoyNut Butter Company. The CDC also urges consumers to check their pantry for SoyNut Butter products.

What are the Symptoms of E. coli O157:H7 Infection?

The symptoms of Shiga toxin-producing E. coli (STEC) infections vary for each person but often include severe stomach cramps and bloody diarrhea. If there is fever, it is usually not very high (less than 101 degrees Fahrenheit disclaimer icon/less than 38.5 degrees Celsius). Most people get better within 5–7 days. Some infections are very mild, but others are severe or even life-threatening.

Around 5–10 percent of those who are diagnosed with STEC infection develop a potentially life-threatening complication, known as hemolytic uremic syndrome (HUS).

Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor. Most people with HUS recover within a few weeks, but some suffer permanent damage or die. People who experience these symptoms should seek emergency medical care immediately. Persons with HUS should be hospitalized because their kidneys may stop working (acute renal failure), but they may also develop other serious problems such as hypertension, chronic kidney disease, and neurologic problems.

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Who is at Risk?

People of any age can become infected. Children under the age of 5 and the elderly are more likely than others to develop severe illness to include HUS, but even healthy older children and young adults can become seriously ill.

What Specific Products were Recalled?

  • Dixie Diner’s Club brand Carb Not Beanit Butter (only available online and through mail order)
  • All flavors and sizes of I.M. Healthy SoyNut Butters
  • All flavors and sizes of I.M. Healthy Granola 

What Do Consumers Need To Do?

Do not eat or serve I.M. Healthy SoyNut Butter or I.M. Healthy Granola, or or Dixie Diner’s Club brand Carb Not Beanit Butter. Even if some of the soynut butter or granola was eaten or served and no one got sick, throw the rest of the product away. Put it in a sealed bag in the trash so that children, pets, or other animals can't eat it.
Contact your health care provider if you think you or your child became ill after eating I.M. Healthy brand SoyNut Butter or I.M. Healthy Granola, or Dixie Diner’s Club brand Carb Not Beanit Butter, especially if you or your child develop diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

What Do Retailers Need To Do?

The SoyNut Butter Company has initiated a voluntary recall of all I.M. Healthy SoyNut Butter and I.M. Healthy Granola products, and Dixie Diner’s Club brand Carb Not Beanit Butter. For questions or concerns, please call the company at 800-288-1012.

Who should be Contacted?

The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time or to consult the FDA website.

Additional Information

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Page Last Updated: 03/21/2017
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