Undeclared Allergens

The leading cause of FDA food recalls — when labels fail to warn about allergens present in the product.

What is Undeclared Allergens?

Undeclared allergens are the single most common reason for FDA food recalls. These recalls occur when a food product contains an allergen that is not listed on the ingredient label, putting consumers with food allergies at risk of a serious or life-threatening allergic reaction (anaphylaxis).

Federal law requires that food labels clearly identify the presence of any of the 9 major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Undeclared allergens typically result from labeling errors, cross-contamination during manufacturing, or the use of an incorrect label on a product.

Symptoms

  • Hives, itching, or skin rash
  • Swelling of the lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Abdominal pain, nausea, or vomiting
  • Dizziness or fainting
  • Anaphylaxis (severe, whole-body reaction — medical emergency)

Onset: Allergic reactions typically occur within minutes to 2 hours of consuming the allergen. Anaphylaxis can develop rapidly and requires immediate epinephrine treatment.

Who is Most at Risk?

Anyone with a known food allergy
Children (who may not recognize early symptoms)
People with asthma (higher risk of severe reactions)
Individuals with a history of anaphylaxis

What Should You Do?

If you have a food allergy and possess a recalled product with an undeclared allergen, do not eat it. Return it to the store for a refund or throw it away.

If you are experiencing an allergic reaction, use your epinephrine auto-injector (EpiPen) immediately and call 911. Do not wait to see if symptoms improve on their own — anaphylaxis can be fatal within minutes without treatment. Even after using epinephrine, go to the emergency room for observation.

Recent Undeclared Allergens Recalls

The latest recalls related to Undeclared Allergens.

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