In consumer packaged goods (CPG), the most serious threats aren’t always the ones grabbing headlines. While supply chain hiccups and microbial contamination often get attention, one issue quietly drives more product removals than any other: the undeclared allergen.
For more than a decade, undeclared allergens, also called “unlabeled allergens” or “hidden allergens,” have consistently topped the list as the primary cause of allergen recall events and CPG product recalls across the United States.
These types of CPG recalls are rarely a result of complicated science, but rather simple, preventable mistakes. An undeclared allergen doesn’t just threaten consumer safety, it can unravel years of brand-building, cause swift financial losses, and permanently damage trust.
While foodborne pathogens may trigger illness, the sheer frequency of CPG recalls stemming from incorrect or missing allergen labels is staggering. For CPG brand managers and compliance officers, understanding and preventing an allergen recall is not just important, it’s essential for long-term success.
Related: Explore our post on How to Stay Ahead of CPG Labeling Regulations in 2026 for a broader look at packaging-related risks.
This post explores why undeclared allergens are known as the "CPG label killer," examines the most current allergen recall data, uncovers root causes behind these CPG recalls, and offers clear steps to protect both your consumers and your brand.
A Decade at the Top: The Data on Allergen Recall and CPG Recalls
The numbers speak for themselves.
Year after year, undeclared allergens are the primary driver behind CPG recalls, consistently outnumbering every other cause in allergen recall statistics. This isn't an occasional problem; it's a systemic vulnerability within the CPG industry.
A look at the data from 2024 and 2025 reveals a persistent trend. Allergen-related issues, particularly failures in declaring food allergens on packaging, have accounted for approximately 26.2% to 34% of all food recall events, making allergen recall the single largest category driving CPG product recalls nationwide.
Primary Data Source: The FDA Data Dashboard (Recalls section) and the USDA FSIS 2024 Annual Recall Summary.
Even more concerning is their severity. Over 22% of all Class I recalls, the most serious category, where there is a reasonable probability that exposure will cause serious adverse health consequences or death, were due to undeclared allergens.
This means that allergen recalls from labeling failures are on par with some of the most dangerous microbial contaminants, highlighting the critical need for better controls in preventing CPG recalls and allergen-related emergencies.
Further reading: Top 5 Challenges in CPG Label Compliance and How to Overcome Them
The Usual Suspects: Primary Culprits and Root Causes
Unlike bacteria that can be neutralized with heat or processing, an undeclared allergen is a permanent part of an ingredient, and its accidental presence is one of the top triggers for major CPG product recalls. Once an undeclared allergen ends up in a product, the only safeguard is clear and accurate labeling. Most allergen recalls and label-based product withdrawals arise not from complex science, but from simple process breakdowns.
The Leading Root Causes
Over 60% of allergen recalls and related CPG recall incidents are caused by labeling and packaging errors that result in undeclared allergens on the shelf.
The most common failures include:
- Sub-Ingredient Blindness: This is a classic scenario where a manufacturer lists "butter" in their ingredient list but fails to declare "Milk" in the "Contains" statement, creating the risk of an undeclared allergen and subsequent allergen recall.
- Packaging Swaps: Human error on the production line leads to the wrong product going into the wrong box, such as a "Cheese Pizza" label on a "Pepperoni Pizza" box, introducing undeclared wheat, soy, or milk that can prompt allergen recalls or widespread CPG recalls.
- Cross-Contact: Equipment shared between product runs, without proper cleaning, results in trace allergens, like peanuts, ending up in products that are supposed to be allergen-free, causing hidden allergen risks and driving recall events.
- Outdated Labels: When formulas change but companies use old packaging, new or different allergen risks are not declared, elevating the chance of an undeclared allergen incident and triggering a CPG allergen recall.
Milk, Wheat, and Soy Lead the Pack
While nine allergens are federally regulated in the United States, a few, especially milk, wheat, and soy, are responsible for the majority of allergen-related food recalls.
These ingredients are so common in processed foods that they often hide in plain sight within flavorings, binders, and additives, making them easy to miss and frequent culprits for CPG recalls and allergen recall cases.
To protect consumers, the FDA requires that labels clearly identify the presence of the nine major food allergens. These "Big Nine" are responsible for over 90% of all documented food allergic reactions in the United States.
- Milk
- Eggs
- Fish
- Shellfish (Crustacean)
- Tree Nuts (e.g., almonds, walnuts, pecans)
- Peanuts
- Wheat
- Soybeans
- Sesame
The addition of sesame as the ninth major allergen, which went into effect in 2023, has had a noticeable impact on allergen recall rates. As brands adjusted their supply chains, cleaning protocols, and labeling processes, the industry saw a corresponding spike in sesame-related recalls.
This highlights how even a single regulatory change can create new compliance challenges for unprepared companies and further underscores the importance of proactive CPG packaging compliance.
Explore more on Navigating CPG Compliance: A Beginner’s Guide
Proactive Measures: Turning a Weakness into a Strength
The persistence of allergen recalls and the ever-present risk of CPG recalls underscores a critical truth: a reactive approach is a failing strategy.
Winning brands treat allergen compliance and proactive allergen recall prevention not as a burden, but as a core tenet of their operational and brand identity, especially given how frequently allergen recall events drive company-wide product removals.
Build a Fortified Review Process
Your label approval workflow is your primary defense against costly CPG recalls triggered by undeclared allergen errors. It must be robust, redundant, and involve multiple departments.
Create a mandatory sign-off process where every label is checked by:
- R&D/Quality: To confirm the ingredient list and nutritional data perfectly match the final formulation.
- Regulatory/Legal: To verify that all allergen declarations are present, accurate, and formatted according to FDA guidelines, reducing the risk of an allergen recall.
- Marketing: To ensure claims like "dairy-free" are substantiated and not contradicted by the ingredient list, preventing possible mislabeling and subsequent CPG recalls.
Centralize Your Data for a Single Source of Truth
Scattered spreadsheets are a recipe for disaster, and, ultimately, for allergen recall exposure or CPG recalls involving food allergens.
Your ingredient specifications, supplier details, and formulation data must live in a single, centralized system, like a Product Lifecycle Management (PLM) platform. When your entire team works from one source of truth, the risk of using outdated or incorrect information on a label plummets, reducing the likelihood of an allergen recall or product withdrawal due to noncompliance.
Embrace Technology and Automation
Manual proofreading is no longer sufficient, especially given the relentless nature of undeclared allergen and allergen recall incidents in the CPG sector.
Human eyes get tired and make mistakes. Modern technology offers a powerful safety net for CPG brands and compliance teams. AI-powered compliance software can scan packaging artwork and instantly compare it against your master data to:
- Verify that every ingredient is listed correctly.
- Flag missing or inaccurate allergen declarations before they result in an allergen recall or CPG-wide recall event.
- Confirm the "Contains" statement matches the ingredients, a crucial step in avoiding CPG recalls tied to allergies.
- Detect if a "free-from" claim is contradicted by the formulation, reducing potential risk for mislabeling and allergen-related recalls.
By automating these tedious checks, you free up your experts to focus on more complex strategic issues, turning your compliance team from reactive problem-solvers into proactive guardians of the brand, making your organization far less vulnerable to allergen recall events or compliance-driven CPG product recalls.
Learn more: How AI is Transforming Label Compliance for CPG Brands
Protect Your Brand by Protecting Your Consumers
Undeclared allergen incidents are far more than a compliance headache, they are frequently the root cause behind serious allergen recall events and ongoing challenges with CPG recalls for brands of all sizes.
The latest data is clear: without airtight processes and modern preventive strategies, even leading brands face significant risk from hidden allergens and mislabeling, which can damage consumer trust and financial performance.
To reduce the likelihood of allergen recalls and protect your business from damaging CPG recalls, prioritize accurate allergen labeling, invest in rigorous approval workflows, and harness technology to eliminate human errors. By proactively addressing the threat of undeclared allergens and allergen recall triggers, you strengthen your brand’s reputation and ensure lasting trust in the highly competitive CPG industry.
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