Undeclared milk in FDA food recalls
2,840 FDA food recall records since 2012 name undeclared milk, out of 7,778 undeclared allergen recalls in total. 1,121 are Class I. Data last updated 2 September 2026.
- Records of 29,386
- 2,840
- Share of all recalls
- 9.7%
- Class I of 2,840
- 1,121
- Reported between
- 2012 to 2026
Milk as a major food allergen
Milk is the most frequently undeclared major allergen in FDA food recalls, and it reaches products through whey, casein and shared equipment far more often than through an ingredient anyone would call milk.
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, Milk is weighted toward snacks and confectionery: 25.4% of the records here against 14.7% across the corpus.
These recalls travel further than most: 31.2% state nationwide distribution, against 20.7% of all records.
What the FDA says
“This requirement is met if the common or usual name of an ingredient already identifies that allergen's food source name (for example, buttermilk).”
Milk is the allergen this exemption covers most often, and it is why an ingredient list can be compliant without the word milk appearing on its own.
“Some dark chocolate products are made without milk as an ingredient, but milk has sometimes been found in these products.”
The FDA's own survey of dark chocolate is the clearest published case of milk reaching a product no recipe called for.
What the law says about milk
Milk is the first food named in the definition of a major food allergen at 21 U.S.C. 321(qq)(1), and under paragraph (2) any ingredient that contains protein derived from milk, whey, casein, caseinates, lactalbumin, is a major food allergen with it. Section 343(w) allows two ways to declare it: the food source in parentheses after the ingredient, whey (milk), or a Contains milk statement immediately after or adjacent to the ingredient list, in type no smaller than the list itself. Section 343(w)(4) extends the requirement to a flavouring, colouring or incidental additive that contains milk, which is where a processing aid that carried casein into a product with no dairy in the recipe stops being exempt.
The clause this maps to
A preventive controls plan covers an undeclared milk 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.
| Year | Recalls reported |
|---|---|
| 2012 | 89 |
| 2013 | 122 |
| 2014 | 253 |
| 2015 | 105 |
| 2016 | 240 |
| 2017 | 934 |
| 2018 | 126 |
| 2019 | 92 |
| 2020 | 94 |
| 2021 | 100 |
| 2022 | 183 |
| 2023 | 191 |
| 2024 | 99 |
| 2025 | 110 |
| 2026 | 102 |
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.187
- Koogee-Queen Anne, LLC78
- NutraCap Labs LLC75
- Channel Fish Processing Co. Inc57
- Silver Moon LP dba Loard's Ice Cream43
- Paradise Flavors LLC39
- National Fish & Seafood, Inc.33
- Giant Eagle, Inc.29
- Chemi- Source Inc, Nutra Pak26
- The Caramel Factory, LLC.25
- GKI Foods, LLC21
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.
- Illinois478
- California312
- New Hampshire194
- Texas146
- New York141
- Florida139
- Pennsylvania137
- Washington116
- Massachusetts115
- Michigan109
- Georgia101
- New Jersey93
Most recently reported
Questions
- How many FDA recalls involve undeclared milk?
- 2,840 FDA food recall records since 2012 name undeclared milk, out of 7,778 undeclared allergen recalls in total. That makes it the most frequently undeclared of the allergens tracked here.
- Is milk a major food allergen?
- Milk is the most frequently undeclared major allergen in FDA food recalls, and it reaches products through whey, casein and shared equipment far more often than through an ingredient anyone would call milk.
- Which clause covers undeclared milk?
- 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.
An undeclared allergen is almost always a specification that did not carry the allergen forward from a supplier document to a label. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.