December 6, 2017

On this page:

• Fast Facts
• What was the Problem and What was Done About It?
• What are the Symptoms of E.coli O121 & O26?
• Who is at Risk?
• What Specific Products were Recalled?
• What Do Restaurants and Retailers Need To Do?
• What Do Consumers Need To Do?
• Who Should be Contacted?
• Final Summary
• Additional Information

The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local public health officials investigated a multi-state outbreak of Shiga toxin-producing Escherichia coli (STEC) O121 and O26 infections. 

Fast Facts

• FDA’s traceback investigation identified flour from General Mills as the source of this outbreak, which led to a voluntary recall in May 2016. FDA tested samples of General Mills flour and in June 2016, detected the presence of E. coli O121, which was subsequently confirmed by whole genome sequencing (WGS). In addition, E.coli O26 was also found to be present, prompting an expanded recall.
• On September 29, 2016, CDC reported that their outbreak investigation is over. Sixty-three people infected with the outbreak strains of E.coli O121 or O26 were reported from 24 states.
• Flour has a long shelf life, and bags of flour may be kept in peoples’ homes for a long time. Consumers unaware of the recall could continue to use these recalled flour products and potentially get sick. If consumers have any of these recalled flour products in their homes, they should throw such flour products away.

What was the Problem and What was Done About It?  

The FDA, CDC, and state and local officials investigated a multi-state outbreak of Shiga toxin-producing Escherichia coli (STEC) O121 and O26 infections.

CDC reports that 63 people infected with the outbreak strains of E. coli O121, and O26 were reported from 24 states. Illnesses started on dates ranging from December 21, 2015 to September 5, 2016. Seventeen ill people were hospitalized, and one person developed hemolytic-uremic syndrome. In its investigation, CDC learned that some people who got sick had eaten or handled raw dough.

FDA’s traceback investigation determined that the raw dough eaten or handled by ill people or used in restaurant locations were made using General Mills flour that was produced in November 2015 and select production dates through February 10, 2016 at the General Mills facility in Kansas City, Missouri. Epidemiology, laboratory and traceback evidence available at that time indicated that General Mills flour manufactured at this facility is the likely source of the outbreak.

On May 31, 2016, following a conference call among FDA, CDC and the firm, General Mills conducted a voluntary recall of flour products produced between November 14, 2015 and December 4, 2015. Recalled products were sold in stores nationwide but may still be in consumers’ pantries and were sold under three brand names: Gold Medal flour, Signature Kitchens flour and Gold Medal Wondra flour. The varieties include unbleached, all-purpose, and self-rising flours.

On June 10, 2016, FDA performed Whole Genome Sequencing (WGS) on E. coli O121 isolates recovered from an open sample of General Mills flour belonging to a Colorado consumer who was sickened, and it was found to be closely related genetically to the clinical isolates from human illnesses. The flour came from a lot that General Mills had recalled.

Testing by FDA has identified E. coli O121 in open product samples collected from ill people in Arizona and Oklahoma. FDA’s WGS analysis of the E.coli O121 isolates from the Arizona and Oklahoma product samples showed that they were  closely related genetically to the outbreak strains. The General Mills flour sample collected from the Oklahoma patient was produced outside of the company’s original recall date range. On July 1, 2016, following a call with the FDA and CDC General Mills expanded its recall of Gold Medal flour, Wondra flour, and Signature Kitchens flour.

The FDA used WGS to characterize isolates provided by General Mills to FDA. FDA provided characterization information to General Mills that an E. coli O26 isolated from their returned retail flour is closely related genetically to a clinical isolate that was subsequently added to the outbreak cluster. WGS characterization analysis of additional E.coli isolates provided by General Mills to FDA did not return other clinical isolates that were closely related genetically.

On July 25, 2016, following a call with the FDA and CDC, General Mills expanded its recall a second time to include products produced on select dates through February 10, 2016.

General Mills also sells bulk flour to customers who use it to make other products. General Mills has contacted these customers directly to inform them of the recall. FDA is working with General Mills to ensure that its customers have been notified, to evaluate the effectiveness of the recall and  monitor the firm’s corrective actions.

In general, supplier-customer relationships are confidential and, because of legal restrictions on disclosure of commercial confidential information, FDA is generally not authorized to release the names of these customers or the products they make with the flour.

Flour has a long shelf life, and bags of flour may be kept in peoples’ homes for a long time. Consumers unaware of the recall could continue to eat these recalled flours and potentially get sick. If consumers have any of these recalled flours in their homes, they should throw such flour products away.

Since the initial recall on May 31, 2016, FDA has facilitated at least 5 recalls of firms that received recalled flour. Listed below are the recalls for which the customer relationship with General Mills has been made public:

On September 29, 2016, CDC reported that their outbreak investigation is over.

What are the Symptoms of E.coli O121 & O26?

People usually get sick from STEC O121 and O26 about 2-8 days (average of 3-4 days) after consuming the contaminated product. Most people develop diarrhea (often bloody) and abdominal cramps. Most people recover within a week.

Some illnesses last longer and can be more severe, resulting in a type of kidney failure called hemolytic uremic syndrome (HUS). HUS can occur in people of any age, but is most common in young children under 5 years, older adults, and people with weakened immune systems.

Symptoms of HUS can include fever, abdominal pain, pale skin tone, fatigue and irritability, small, unexplained bruises or bleeding from the nose and mouth, and decreased urination.

People who experience these symptoms should seek emergency medical care immediately.

Who is at Risk?

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

What Specific Products were Recalled?

Recalled products were sold in stores nationwide but may still be in consumers’ pantries and were sold under three brand names: Gold Medal Flour, Signature Kitchens Flour, and Gold Medal Wondra flour. The recalled products were sold nationwide and include unbleached, all-purpose, and self-rising flours varieties.

On July 1, 2016, General Mills issued an expanded recall to include 8 SKUs (stock keeping units or UPC codes) of Gold Medal Flour, 1 SKU of Signature Kitchens Flour and 1 SKU of Gold Medal Wondra flour. Consumers, restaurants, and retailers should not use, serve, or sell the recalled flours.

On July 25, 2016, following a call with the FDA and CDC, General Mills expanded its recall a second time to include products produced on select dates through February 10, 2016.

The July 25, 2016 expanded recall products include: 

The May 31, 2016 and July 1, 2016 recalled products include:

Restaurants and retailers should throw away any recalled General Mills flour. Some ill people reported handling raw dough at restaurants prior to eating their meal. Restaurants that allow their customers to handle raw dough should evaluate whether this practice is appropriate.

Restaurants and retailers should be aware that flour may be a source of pathogens and should control the potential for cross-contamination of food processing equipment and the food processing environment. They should follow the steps below:

• Wash and sanitize display cases and refrigerators where potentially contaminated flour was stored.
• Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated flour.
• Wash hands with hot water and soap following the cleaning and sanitation process.
• Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross contamination of cutting surfaces and utensils through contact with the potentially contaminated flour.
• Regular frequent cleaning and sanitizing of food contact surfaces and utensils used in food preparation may help to minimize the likelihood of cross-contamination. 

What Do Consumers Need To Do?

The recalled General Mills products have a long shelf-life, and may still be present in peoples’ homes. Consumers unaware of the recall could continue to eat these products and potentially get sick.

If consumers have one or more of these products in their homes, they should throw them away. As a precaution, flour no longer stored in its original packaging should be discarded if it could be covered by this recall, and the containers used to store this flour should be thoroughly washed and sanitized.

Three people who became ill reported handling raw dough at restaurants prior to eating their meal. As a precaution, consumers, especially children, should not handle raw dough at home or at restaurant locations. The FDA recommends following these safe food-handling practices to stay healthy:

• Do not eat or play with any raw cookie dough or any other raw dough product made with flour that is intended to be cooked or baked.
• Follow package directions on baking mixes and other flour-containing products for proper cooking temperatures and for specified times.
• Wash hands, work surfaces, and utensils thoroughly after contact with raw dough products containing flour.
• Keep raw foods separate from other foods while preparing them to prevent any contamination that might be present from spreading.  

FDA warns against eating raw dough products made with any brand of flour or baking mix before cooking. Consumers should always practice safe food handling and preparation measures when handling flour.

Who Should be Contacted?

Contact your healthcare provider if you have 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.

Consumers with additional questions should contact the company at 800-230-8103. Additional recall information can also be found at http://www.generalmills.com/flour.

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.gov website: http://www.fda.gov.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

Additional Information

• Foodsafety.gov:  Food Poisoning - E. coli
• CDC:  CDC E. coli homepage 
• FDA Voice Blog: Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour
• Consumer Update: Raw Dough's a Raw Deal and Could Make You Sick