Undeclared allergens in FDA food recalls

7,778 of the 29,386 FDA food recall records published since 2012 name an undeclared allergen. That is 26.5% of every food recall the agency has reported, and 2,563 of them are Class I. Data last updated 2 September 2026.

Records of 29,386

7,778

Share of all recalls

26.5%

Class I of 7,778

2,563

Reported between

2012 to 2026

What is different about these records

By product, Undeclared allergens is weighted toward bakery: 22.3% of the records here against 12.9% across the corpus.

Recalls involving undeclared allergens skew less severe than the corpus: 33% are Class I against 44% nationally.

What the FDA says

What Undeclared allergens means in a recall record

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

The firm with the most records of this kind is Newly Weds Foods Inc, with 369. A high count usually reflects one event split across many product codes rather than many separate failures, which is why the table below is ordered by date rather than by firm.

The clause this maps to

A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 117.135(c)(2)

Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.

21 CFR 101.4

Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.

21 CFR 117 subpart G

Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

By year

Counts are by the date the FDA reported the enforcement action. That date runs behind the date a firm started a recall, so the most recent year is always partial.

Firms with the most records

A firm appears here because it reported recalls, which is what a working recall procedure produces. A high count frequently reflects a single event split across many product codes rather than many separate failures.

• Newly Weds Foods Inc369
• High Liner Foods Inc.188
• Albertsons Companies LLC132
• NutraCap Labs LLC106
• Whole Foods Market94
• Wegmans Food Markets, Inc.79
• Mira Health Products Ltd.79
• Koogee-Queen Anne, LLC78
• CSM Bakery Products NA66
• Channel Fish Processing Co. Inc57
• Creative Foodworks, Inc57
• Giant Eagle, Inc.55

Where the recalling firms are

The state is the location of the recalling firm, not where the product was sold. Distribution is recorded separately on each record.

• California851
• New York658
• Illinois626
• Texas593
• Washington376
• Georgia357
• New Jersey356
• Pennsylvania346
• Florida329
• Michigan327
• Oregon280
• Massachusetts250

Most recently reported

Questions

How many FDA food recalls involve undeclared allergens?

7,778 of the 29,386 FDA food recall records published since 2012 name an undeclared allergen, which is 26.5% of all of them. 2,563 are Class I, the class the FDA uses when there is a reasonable probability of serious health consequences or death.

What is Undeclared allergens?

An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.

Which clause covers an undeclared allergen?

A preventive controls plan under 21 CFR 117 covers an undeclared allergen under 21 CFR 117.135(c)(2), 21 CFR 101.4, 21 CFR 117 subpart G. Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label. This is where the control belongs; a recall record states a reason rather than a regulatory finding, and most FDA food recalls are initiated by the firm itself.

All FDA food recall data