Undeclared wheat in FDA food recalls

1,396 FDA food recall records since 2012 name undeclared wheat, out of 7,778 undeclared allergen recalls in total. 285 are Class I. Data last updated 2 September 2026.

Records of 29,386

1,396

Share of all recalls

4.8%

Class I of 1,396

285

Reported between

2012 to 2026

Wheat as a major food allergen

Wheat is a major food allergen and is separate from gluten, which is a labelling claim rather than an allergen: a product can be free of wheat and still fail a gluten-free claim.

These records are a subset of the 7,778 undeclared allergen recalls. A single recall frequently names more than one allergen, so the counts across this family overlap. 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.

What is different about these records

By product, Wheat is weighted toward bakery: 36.6% of the records here against 12.9% across the corpus.

Recalls involving undeclared wheat skew less severe than the corpus: 20.4% are Class I against 44% nationally.

A recall involving undeclared wheat stays open a median of 152 days between the report and termination, against 215 days for the corpus as a whole. Termination follows the firm accounting for every unit of the affected lot.

These recalls stay local: 8% state nationwide distribution, against 20.7% across the corpus.

What the FDA says

What the law says about wheat

Wheat is one of the nine in 21 U.S.C. 321(qq)(1); the other gluten-containing grains, rye and barley, are not. Gluten is a separate regime. 21 CFR 101.91 defines the gluten-containing grains as wheat, rye and barley and their crossbred hybrids, and defines a gluten-free claim as a food that contains no ingredient that is one of those grains or an unprocessed derivative of one, and that contains less than 20 parts per million of gluten. A product can therefore be recalled for undeclared wheat under section 343(w) without ever having made a gluten-free claim, or for a false gluten-free claim under 101.91 without containing wheat, and a rye-flour recall is the second kind only.

The clause this maps to

A preventive controls plan covers an undeclared wheat 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.

• Koogee-Queen Anne, LLC78
• Houston Pecan Company, Inc31
• Lemonland Food Corp28
• Reisman Bros Bakery24
• The Pastene Companies Ltd.24
• McClures, Inc.23
• Lavoi Corporation d/b/a/ Epi De France22
• Chicago Sweet Connections, Inc.20
• Crescent Vending Co. Inc.20
• Custom Ingredients LLC20
• E. Franco & Co. Inc17
• NatureMills US Incorporated16

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.

• California166
• Washington150
• Texas142
• Kentucky82
• New York78
• Pennsylvania74
• Oregon73
• Florida64
• Illinois53
• Puerto Rico48
• Michigan43
• Georgia43

Most recently reported

Questions

How many FDA recalls involve undeclared wheat?

1,396 FDA food recall records since 2012 name undeclared wheat, out of 7,778 undeclared allergen recalls in total. That makes it the third most frequently undeclared of the allergens tracked here.

Is wheat a major food allergen?

Wheat is a major food allergen and is separate from gluten, which is a labelling claim rather than an allergen: a product can be free of wheat and still fail a gluten-free claim.

Which clause covers undeclared wheat?

Allergen labelling failures are covered under 21 CFR 117.135(c)(2), the food allergen preventive controls, together with 21 CFR 101.4 for the ingredient declaration itself. Where the allergen arrived inside a purchased ingredient, the supply-chain programme in 21 CFR 117 subpart G is the control that should have caught it.

All FDA food recall data