FDA Investigates Complaints Associated with Cheerios Labeled Gluten Free: General Mills Voluntarily Recalls Affected Lots

What is the problem and what is being done about it?

The U.S. Food and Drug Administration is investigating reports of adverse reactions associated with eating original Cheerios and Honey-Nut Cheerios labeled as gluten-free and working with General Mills to facilitate their voluntary recall of these products. We recognize the importance of this issue to people with celiac disease, wheat allergy, and gluten sensitivity, and we will continue to provide updates and advice as needed.

After learning of these adverse reactions, the FDA tested 36 samples of Cheerios products labeled as gluten-free from different manufacturing facilities and lots. Although most of the samples met the definition for “gluten-free,” one sample of General Mills Honey Nut Cheerios labeled as gluten-free contained 43 parts per million (ppm) of gluten. This exceeds one of the criteria for FDA’s gluten-free definition, that the food contain less than 20 ppm of gluten.

General Mills has voluntarily recalled 13 production lots of Honey Nut Cheerios labeled as gluten-free and 4 production lots of original (yellow box) Cheerios labeled as gluten-free due to the presence of wheat flour (an undeclared allergen).  As with all recalls, the FDA will work to ensure the recall is effective and the underlying cause is identified and addressed.

Who is at risk?

People with celiac disease or wheat allergy are at risk. People who are sensitive to gluten may also want to be aware.

What symptoms might people with celiac disease experience?

Gluten is the protein that naturally occurs in wheat, rye, barley, and crossbreeds of these grains. Most people can eat gluten, but in people with celiac disease, gluten intake gradually damages the intestines, prevents the absorption of vitamins and minerals, and can lead to other health problems. Symptoms can include diarrhea, fatigue, headaches, abdominal pain, brain fog, rashes, nausea, vomiting, and other reactions.

What symptoms might people with wheat allergy experience?

People who have an allergy to wheat run the risk of serious or life-threatening allergic reaction if they eat wheat. Symptoms may include swelling, itching or irritation of mouth or throat, difficulty breathing, nasal congestion, itchy or watery eyes, rash or hives, headaches, nausea, vomiting, cramps, diarrhea, or anaphylaxis, a potentially life-threatening reaction.

What specific products has General Mills recalled?

The voluntary recall is for products that were manufactured on certain dates in the Lodi, California facility. These specific boxes of original (yellow box) Cheerios and Honey Nut Cheerios, both labeled as gluten-free, carry the following “BETTER IF USED BY” code dates and the plant code LD, which indicates the product was produced at the Lodi, California facility:

Honey Nut Cheerios

  • 12JUL2016LD
  • 13JUL2016LD
  • 14JUL2016LD
  • 15JUL2016LD
  • 16JUL2016LD
  • 17JUL2016LD
  • 18JUL2016LD
  • 20JUL2016LD
  • 21JUL2016LD
  • 22JUL2016LD
  • 23JUL2016LD
  • 24JUL2016LD
  • 25JUL2016LD 

Yellow Box Cheerios

  • 14JUL2016LD
  • 15JUL2016LD
  • 16JUL2016LD
  • 17JUL2016LD

No other General Mills product is affected by this recall.

What should consumers do?

Consumers with celiac disease or wheat allergy should avoid eating Cheerios or Honey Nut Cheerios labeled as gluten-free from the recalled lots. Those with gluten sensitivity may also want to be aware. Consumers who believe they are having an adverse event related to eating Cheerios or Honey Nut Cheerios labeled as gluten-free should stop eating these cereals and seek medical care or advice.

Both consumers and their health care providers can report these adverse events to the FDA using MedWatch, the FDA Safety Information and Adverse Event Reporting Program. To report by telephone, call 1-800-332-1088.

Consumers and manufacturers can also report any complaint they may have about an FDA-regulated food (e.g., concerns about gluten-free claims on food labels) to an FDA Consumer Complaint Coordinator in the state where the food was purchased. A list of FDA Consumer Complaint Coordinators is posted on FDA’s website.

What should retailers (grocery stores) do?

Retailers should work directly with General Mills to comply with the recall.

Who should be contacted with questions about the product?

Consumers with questions about the product may contact General Mills Consumer Services at 1-800-775-8370. 

Additional Information

Page Last Updated: 10/13/2015
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