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IM Healthy SoyNut Butter Outbreak and Recall

What started as an unidentified cluster of 10 cases of a rare form of E. coli O157:H7 has now become a national outbreak. The Centers for Disease Control and Prevention (CDC), together with the Food and Drug Administration (FDA) and various local state health departments, confirmed a link of the mystery illnesses to one common source – I. M. Healthy SoyNut Butter products produced and manufactured by The SoyNut Butter Company. The Illinois –based retailer sells its products in grocery and health stores nationwide, as well as through online retailers. The FDA confirmed the link between the I. M. Healthy SoyNut Butter products and the E. coli O157:H7 cases on March 6, 2017. Fifteen out of fifteen people currently interviewed by the CDC corroborate eating soynut butter products made by The SoyNut Butter Company prior to their illnesses.

Currently, the CDC confirms 16 cases in 9 states, Arizona, California, Maryland, Missouri, New Jersey, Oregon, Virginia, Washington, and Wisconsin. Fourteen of the 16 cases involve a child under the age of 18 years old. Eight people have been hospitalized and there are 5 cases of hemolytic uremic syndrome (HUS). At this time, no deaths have been reported. The victims range in age from 2 to 48 years old. Their illnesses range from January 4, 2017 to February 21, 2017.

The Link and Ensuing Recalls

After the company’s initial denials of their involvement, the CDC and FDA contacted The SoyNut Butter Company. The Maryland Department of Health and Mental Hygiene (MDHMH) notified the public that its E. coli O157:H7 case confirmed in an interview to ingesting soynut butter with the I. M. Healthy SoyNut Butter brand prior to becoming sick. According to the notice, the MDHMH urged its residents to stop eating any I. M. Healthy SoyNut Butter products.

After this notice, The SoyNut Butter Company initiated its first voluntary recall. The recall was general and narrow, only recalling specific I. M. Healthy SoyNut Butter products in jars with the Best Buy dates of August 30, 2018 or August 31, 2018. The CDC and FDA, however, believed that more products were potentially contaminated. Upon the launch of the CDC’s outbreak page for the Multistate Outbreak of Shiga toxin-producing Escherichia coli O157:H7 Infections Linked to I.M. Healthy Brand SoyNut Butter, the agency was quick to note that it recommended, “consumers do not eat any I.M. Healthy brand SoyNut Butter varieties or sizes or I.M. Healthy brand granola coated with SoyNut Butter. Childcare centers, schools, and other institutions should not serve I.M. Healthy brand SoyNut Butter or I.M. Healthy brand granola coated with SoyNut Butter. Multiple varieties and sizes of I.M. Healthy brand SoyNut butter and I.M. Healthy brand granola coated with SoyNut Butter are sold nationwide in stores, online, and to institutions. The products have a shelf life of 2 years.”

During this time, the Arizona Department of Health Services (ADHS) and the California Department of Public Health (CDPH) joined in with their support of the CDC and FDA’s guidance. According to CDPH’s Director and State Public Health Officer Dr. Karen Smith, “Consumers who purchased Creamy SoyNut Butter or coated granola should dispose of the product immediately, even if it was already eaten and didn’t cause illness.”

A day or so later, The SoyNut Butter Company responded to the outcry with a recall expansion, ineptly ignoring the coated granola products and other I. M. Healthy SoyNut Butter brand flavors. The second stage of the voluntary recall identified varieties of the products from the first recall, including: 15 ounce plastic jars with the Best By dates July 5, 2018, August 30, 2018, and August 31, 2018, individual portion cups with the Best By date as August 8, 2018, and 4 pound plastic tubs with Best By dates of November 16, 2018 and July 25, 2018. Again, the company was mum about the granola. By this time, the ADHS mentioned that it believed the granola may be to blame for several illnesses of E. coli O157:H7 from daycare children. Retailers began pulling The SoyNut Butter Company products off of their shelves.

As the case count grew and the media began to wonder why the granola products remained on the market, the company decided to initiate another expansion to their recall. On March 7, 2017, the company finally recalled its granola products, as well as the other flavors of the I. M. Healthy SoyNut Butter brand. The recent recall notice on its website reads:

“Please note that the SoyNut Butter Co. has expanded our voluntary recall to include ALL I.M. Healthy SoyNut Butters and I.M. Granola effective immediately. Regardless of Best Buy date or variety, we recommend that you do not consume I.M. Healthy SoyNut Butter or I.M. Healthy Granola and return it to the store full a full refund.

For over 20 years, the SoyNut Butter Co. has tried to make nut free products that help those with allergies eat like everyone else. Likewise, we chose our contract manufacturer because of their integrity and knowledge of food safety and quality. Unfortunately, we feel that is better to be cautious regarding public safety and urge our customers to heed the expanded recall. We have enjoyed serving you and will do everything we can possibly do to assist the FDA in this outbreak.”

The website notification again remained vague. Fortunately, the FDA provided a more specific recall notice on its outbreak page, as follows:

“The SoyNut Butter Company has recalled all lots of I.M. Healthy SoyNut Butter and I.M. Health Granola because they may be contaminated with Shiga toxin-producing Escherichia coli (E. coli) O157:H7 bacteria. All Best Buy 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 and FDA, with the support of many state local health departments, remain steadfast in their warnings to consumers to not eat any I. M. Healthy SoyNut Butter products. The agencies continue to work together to identify any additional cases or potential contaminated products. It appears that the agencies involved believed more cases (and possibly products) may be linked to this outbreak.

E. coli O157:H7

Even though no cases have yet been reported in their state, the Illinois Department of Public Health (IDPH) has also reported warnings against eating the affected products. According to the IDPH Public Health Director Nirav D. Shah, M.D., J.D., “Some infections of E. coli are mild, but others can be severe or even life-threatening, especially for young children. If you have recently purchased soy nut butter, please check the label for the brand and throw it out if it is part of this recall.”

Knowing the signs and symptoms of E. coli infections are helpful for the recovery process. Symptoms typically include: nausea, vomiting, watery diarrhea (which can become bloody), and abdominal pain. A low grade fever is also sometimes present. The latency period is anywhere from 1 to 9 days. It is recommended that anyone who has consumed any of the affected products and are showing any of the above symptoms seek medical attention. Immediate medical attention can assist with a quicker recovery and help avoid the risk of further complications, including hemolytic uremic syndrome.

For more information about E. coli or this outbreak, please visit our blog at www.UnsafeFoods.com.

If you or someone in your family has become ill or injured from eating an I. M. Healthy SoyNut Butter product made by The SoyNut Butter Company, we are here to answer your questions, address your concerns, and help you through the legal process. You can reach us at (855) 969-5637.

We welcome your calls, letters and electronic mail. Neither the completion of an intake nor the submission of any other information to this law firm constitutes the establishment of an attorney client relationship. No attorney client relationship will exist between us without a specific written retainer agreement between you and this firm. The information you obtain at this site is not, nor is it intended to be, legal advice. Please do not send any confidential information to us until such time as an attorney-client relationship has been established.

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