FDA Investigates Multistate Outbreak of E. coli O121 Infections Linked to Flour
Update: July 1, 2016
The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multi-state outbreak of Shiga toxin-producing Escherichia coli O121 (STEC O121) infections.
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.
Testing by FDA has now identified E. coli O121 in open product samples collected from ill people in Arizona and Oklahoma. FDA whole genome sequencing of the E.coli O121 isolate from the Arizona product sample is closely genetically related to the outbreak strain. Pulsed-field gel electrophoresis (PFGE) shows that the Oklahoma product sample isolates match the outbreak strain. The General Mills flour sample collected from the Oklahoma patient was purchased outside of the company’s original recall date range.
What is the Problem and What is Being Done About It?
The FDA, CDC and state and local officials are investigating a multi-state outbreak of Shiga toxin-producingEscherichia coli O121 (STEC O121) infections.
The
CDC reports that 42 people infected with the outbreak strain of
E. coli O121 have been reported from 21 states. Illnesses started on dates ranging from December 21, 2015 to June 8, 2016. Eleven ill people have been hospitalized. 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 was made using General Mills flour that was produced in November 2015 at the General Mills facility in Kansas City, Missouri. Epidemiology, laboratory and traceback evidence available at this time indicate 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 are sold in stores nationwide or may be in consumers’ pantries and are 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 whole genome sequencing on E. coli O121 isolates recovered from an open sample of General Mills flour belonging to a Colorado consumer who was sickened was found to be closely genetically related the clinical isolates from human illnesses. The flour came from a lot that General Mills has recalled.
Testing by FDA has now identified E. coli O121 in open product samples collected from ill people in Arizona and Oklahoma. FDA whole genome sequencing of the E.coli O121 isolate from the Arizona product sample is closely genetically related to the outbreak strains Pulsed-field gel electrophoresis (PFGE) shows that the Oklahoma product sample isolates match the outbreak strain. The General Mills flour sample collected from the Oklahoma patient was purchased 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.
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 the customers have been notified, and to evaluate the recall for effectiveness. Because of legal restrictions on disclosure of commercial confidential information, FDA is not at this time 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 them away.
The investigation is ongoing and FDA will provide updated information as it becomes available.
What are the Symptoms of E.coli O121?
People usually get sick from STEC O121 2-8 days (average of 3-4 days) after swallowing the bacteria. 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.
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 are Being Recalled?
Recalled products are currently sold in stores or may be in consumers’ pantries and are 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 do not use, serve, or sell the recalled flours.
The specific products in the recall include:
13.5oz Gold Medal Wondra Flour
|
Package UPC
|
000-16000-18980
|
|
Recalled Better if Used by Dates
|
25FEB2017 thru 30MAR2017
Added July 1, 2016:
23FEB2017KC, 24FEB2017KC
|
2lb Gold Medal All Purpose Flour
|
Package UPC
|
000-16000-10710
|
|
Recalled Better if Used by Dates
|
25MAY2017KC thru 03JUN2017KC
Added July 1, 2016:
15MAY2017KC through 24MAY2017KC, 04JUN2017KC, 05JUN2017KC, 11JUN2017KC, 12JUN2017KC, 13JUN2017KC, 14JUN2017KC
|
2lb Gold Medal Self-Rising Flour
|
Package UPC
|
000-16000-11710
|
|
Recalled Better if Used by Dates
|
23AUG2016KC
Added July 1, 2016:
09AUG2016KC, 10AUG2016KC, 16AUG2016KC, 17AUG2016KC, 06SEP2016KC, 07SEP2016KC
|
10lb Gold Medal All Purpose Flour
|
Package UPC
|
000-16000-10410
|
|
Recalled Better if Used by Dates
|
02JUN2017KC, 03JUN2017KC
Added July 1, 2016:
16MAY2017KC through 20MAY2017KC, 05JUN2017KC
|
|
5lb Gold Medal All Purpose Flour
|
Package UPC
|
000-16000-10610
|
|
Recalled Better if Used by Dates
|
25MAY2017KC, 27MAY2017KC thru 31MAY2017KC, 01JUN2017KC, 03JUN2017KC thru 05JUN2017KC, 11JUN2017KC thru 14JUN2017KC
Added July 1, 2016:
15MAY2017KC through 24MAY2017KC
|
5lb Gold Medal Unbleached Flour
|
Package UPC
|
000-16000-19610
|
|
Recalled Better if Used by Dates
|
25MAY2017KC, 27MAY2017KC, 03JUN2017KC, 04JUN2017KC
Added July 1, 2016:
19MAY2017KC through 24MAY2017KC, 11JUN2017KC, 12JUN2017KC
|
Added July 1, 2016
5lb Gold Medal Self-Rising Flour
|
Package UPC
|
000-16000-11610
|
|
Recalled Better if Used by Dates
|
10AUG2016KC, 11AUG2016KC
|
Added July 1, 2016
4.25lb Gold Medal All Purpose Flour
|
Package UPC
|
000-16000-12670
|
|
Recalled Better if Used by Dates
|
21MAY2017KC, 03JUN2017KC
|
10lb Gold Medal All Purpose Flour- Banded Pack
|
Package UPC
|
000-16000-10410
|
|
Recalled Better if Used by Dates
|
03JUN2017KC, 04JUN2017KC, 05JUN2017KC
|
Added July 1, 2016
10lb Gold Medal All Purpose Flour- Banded Pack
|
Package UPC
|
000-16000-10650
|
|
Recalled Better if Used by Dates
|
15MAY2017KC
|
5lb Signature Kitchens All Purpose Flour Enriched Bleached
|
Package UPC
|
000-21130-53001
|
|
Recalled Better if Used by Dates
|
BB MAY 28 2017
|
5lb Signature Kitchens Unbleached Flour All Purpose Enriched
|
Package UPC
|
000-21130-53022
|
|
Recalled Better if Used by Dates
|
BB MAY 27 2017
|
Added July 1, 2016
2lb Signature Kitchens All Purpose Flour Enriched Bleached
|
Package UPC
|
000-21130-53000
|
|
Recalled Better if Used by Dates
|
BB MAY 27 2017
|
What Do Restaurants and Retailers Need To Do?
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 products were stored.
- Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products.
- 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 products.
- 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 they may be in peoples’ homes. Consumers unaware of the recall could continue to eat these products and potentially get sick.
If consumers have these products in their homes, they should throw it 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.
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. 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.
Contact your healthcare provider if you have diarrhea that lasts for more than 3 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
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:
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.
