Undeclared soy in FDA food recalls

1,478 FDA food recall records since 2012 name undeclared soy, out of 7,778 undeclared allergen recalls in total. 466 are Class I. Data last updated 2 September 2026.

Records of 29,386

1,478

Share of all recalls

5%

Class I of 1,478

466

Reported between

2012 to 2026

Soy as a major food allergen

Soy is usually undeclared as lecithin, an emulsifier that arrives inside another ingredient and is easy to lose track of between a supplier's specification and a finished label.

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, Soy is weighted toward bakery: 28.8% of the records here against 12.9% across the corpus.

Recalls involving undeclared soy skew less severe than the corpus: 31.5% are Class I against 44% nationally.

A recall involving undeclared soy stays open a median of 131 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: 6.4% state nationwide distribution, against 20.7% across the corpus.

What the FDA says

What the law says about soy

Soybeans are one of the nine foods in 21 U.S.C. 321(qq)(1), and an ingredient containing soy protein is a major food allergen under paragraph (2). The one statutory exception matters more for soy than for any other allergen: paragraph (2)(A) excludes any highly refined oil derived from a listed food and any ingredient derived from that oil, so refined soybean oil is not a major food allergen and need not be declared as one. Soy lecithin is not an oil and is not excluded, which is why the records on this page are about lecithin and not about oil.

The clause this maps to

A preventive controls plan covers an undeclared soy 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.

• Wegmans Food Markets, Inc.41
• Dolcetta Artisan Sweets26
• Wysong Corporation25
• The Caramel Factory, LLC.25
• Lemonland Food Corp23
• Whole Foods Market Group Inc.21
• Crescent Vending Co. Inc.20
• Cass Clay Creamery AMPI Fargo Division20
• Pecan Shed18
• Windy Hill Chocolate LLC17
• Alaska Pasta Company17
• Cassanos Inc16

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.

• Washington173
• California139
• Florida101
• New York98
• Oregon98
• Michigan77
• Pennsylvania72
• Texas63
• Ohio57
• Puerto Rico55
• Georgia40
• North Carolina38

Most recently reported

Questions

How many FDA recalls involve undeclared soy?

1,478 FDA food recall records since 2012 name undeclared soy, out of 7,778 undeclared allergen recalls in total. That makes it the second most frequently undeclared of the allergens tracked here.

Is soy a major food allergen?

Soy is usually undeclared as lecithin, an emulsifier that arrives inside another ingredient and is easy to lose track of between a supplier's specification and a finished label.

Which clause covers undeclared soy?

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