Undeclared allergens continue to be one of the top causes of food recalls and 2020 is following suit—especially during the pandemic. The COVID-19 crisis has led to supply chain management challenges for food manufacturers and processors, ingredient suppliers, vendors and regulators.

What are undeclared allergens?

The Food Allergy and Research Organization estimates that 15 million Americans have food allergies, which includes over 5 million children under the age of 18—roughly 1 in every 13 children. The frequency of severe allergic reactions to food has increased exponentially, rising to over 300 percent from 2007 to 2016. 1 

Given the serious risk of anaphylactic food reactions, if you’re allergic to a food ingredient, you probably look very carefully for it on a food product’s label. Those not listed on the label yet included (intended or accidently) are referred to as “undeclared allergens”.  

With the implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), federal law requires the labels of FDA-regulated foods to identify major food allergens that can cause potentially life-threatening reactions for some people. These allergens might include milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The allergens most often involved in recalls have been milk, wheat, and soy. A food product with a label that omits required allergen information is misbranded and can be seized by FDA.2

USDA recalls due to undeclared allergens

Certainly, the coronavirus (COVID-19) pandemic has made 2020 very unique and surreal, yet one of the top food recall contenders with both the FDA and USDA has remained constant—undeclared allergens. While recalls have dropped significantly this year with the pushback of inspections due to the pandemic, undeclared allergens were still the cause of 8 of the 15 recalls the USDA has conducted year to date, affecting 53,436 pounds of meat and poultry3. Prior to the pandemic, between 2014-2019, undeclared allergens were the cause of 246 different recall events affecting more than 29 million pounds of food under USDA jurisdiction, that’s an average of over 40 recalls and 4.8 million pounds of meat and poultry per year4.    

Q1 2020 Notable FDA Recall Numbers5

Undeclared allergens have been the leading cause of food recalls requested by the FDA and are continuing to be in 2020.

FDA Recalls

  • 141 recalls affecting more than 8.8 million units
  • Undeclared allergens equal 39.7% of recalls—top cause of recalls for the 11th consecutive quarter
  • Bacterial contaminations: 58.1% of recalls by number of impacted units
  • Nearly 20% of fresh and processed food recalls impacted products distributed nationwide

Top reasons for errors6

  1. Data shows that labeling errors often occur when the wrong label is applied which fails to list an allergen—commonly when look-alike packaging is used.
  2. New technologies to print labels directly on packaging—saving cost but presenting new errors.
  3. Lack of procedures for tracking within production facilities (packaging, labels and ingredients)

The FDA is working on ways to reduce the number of such recalls, including:6

  1. Researching the causes of these errors
  2. Developing industry best practices
  3. Creating new ways to test for the presence of allergens


  1. The Rise of Undeclared Allergens”, Food Quality & Safety, August 20, 2018
  2. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)”, FDA, July 16, 2018
  3. Current Recalls and Alerts“, USDA, October 28, 2020
  4. USDA Summary of Recall Cases in Calendar Year 2014, 2015, 2016, 2017, 2018 and 2019”, FSIS USDA
  5. Undeclared Allergens, Bacterial Contamination Top Q1 2020 Recalls”, Food Safety Tech, June 9, 2020
  6. Finding Food Allergens Where They Shouldn’t Be”, FDA, Oct. 2014

Disclaimer: Berkley Global Product Recall is pleased to share this material with its customers. Please note, however, that nothing in this document should be construed as legal advice or the provision of professional consulting services. This material is for general informational purposes only, and while reasonable care has been utilized in compiling this information, no warranty or representation is made as to accuracy or completeness.