Undeclared Allergens: What Food Manufacturers Must Know

Last updated: 2026-04-08

When Schreiber Foods, Inc. of Green Bay, WI issued a voluntary recall of 144 cases of Honey Almond Cream Cheese Spread due to undeclared almonds, the headlines focused on the product. But for food manufacturers, the real story is what this recall reveals about the ongoing, preventable gap between what's in a product and what appears on its label. Undeclared allergen recalls are not freak accidents — they are systemic failures, and they are among the most common and most dangerous enforcement triggers FDA pursues.

This article breaks down the regulatory framework behind allergen labeling, what likely went wrong at Schreiber Foods, and — most importantly — the practical steps your facility must take today to avoid the same outcome.

Why Undeclared Allergen Recalls Are a Top FDA Enforcement Priority

Undeclared allergens are consistently the number one cause of FDA food recalls, accounting for approximately 40% of all Class I food recalls in recent years, according to FDA recall data. Class I recalls represent situations where there is a reasonable probability that consuming the product will cause serious adverse health consequences or death.

The stakes are not abstract. According to Food Allergy Research & Education (FARE), more than 33 million Americans live with food allergies, including roughly 7 million adults and 6 million children. Tree nuts — the allergen category that includes almonds — are among the "Big Nine" major food allergens recognized under U.S. law. For individuals with a tree nut allergy, even trace exposure can trigger anaphylaxis, a potentially fatal immune response requiring emergency intervention.

FDA receives reports of approximately 30,000 emergency room visits per year attributable to food allergic reactions, underscoring why mislabeled or unlabeled allergens are treated as a life-safety issue, not a paperwork problem.

Citation hook: Undeclared allergens represent the single largest category of FDA Class I food recalls, making robust allergen control programs not merely a best practice but a legal and moral imperative for food manufacturers.

The Schreiber Foods Recall: What the FDA Alert Tells Us

According to the FDA safety alert (FDA Recall Notice), Schreiber Foods, Inc. voluntarily recalled 144 cases of Honey Almond Cream Cheese Spread because the product may contain undeclared almonds — a major tree nut allergen. Consumers with an allergy or severe sensitivity to almonds face the risk of serious or life-threatening allergic reactions if they consume this product.

The product itself is, by name, a Honey Almond Cream Cheese Spread — meaning almonds are an intentional ingredient. This means the failure was almost certainly a labeling or packaging control breakdown, not a cross-contact contamination event. That distinction matters enormously from a compliance standpoint.

When an intentional allergen-containing ingredient fails to appear on a label, the root cause typically falls into one of three categories:

1. Label version control failure — An older label version without the correct allergen declaration was applied to product.
2. Mislabeling at packaging — The wrong label was applied to the correct product, or the correct label was applied to the wrong product.
3. Formulation change without label update — A new ingredient was introduced without triggering a label review and update workflow.

Each of these root causes points directly to gaps in Preventive Controls under 21 CFR Part 117, the regulation that governs Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human food.

The Regulatory Framework: What the Law Actually Requires

FALCPA and FASTER Act: The Allergen Labeling Baseline

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established the original legal requirement for declaring major food allergens on food labels. Under FALCPA, manufacturers must declare the presence of the eight major allergens — milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans — either within the ingredient list or in a separate "Contains" statement.

The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 expanded this list, adding sesame as the ninth major allergen, effective January 1, 2023. Any food manufacturer that has not yet updated labels and preventive control programs to include sesame is currently out of compliance with federal law.

21 CFR Part 117: Preventive Controls Are Mandatory, Not Optional

Under 21 CFR Part 117, Subpart C, food manufacturers subject to the Preventive Controls rule (most facilities with more than $1 million in annual food sales) are required to:

• Conduct a hazard analysis that specifically considers allergen hazards (§117.130)
• Implement allergen preventive controls where allergen hazards are identified as requiring a preventive control (§117.135(c)(2))
• Establish monitoring procedures for those controls (§117.145)
• Implement corrective action procedures when controls are not properly implemented (§117.150)
• Conduct verification activities to confirm controls are working (§117.155)
• Maintain records of all of the above (§117.190)

Critically, §117.135(c)(2) explicitly calls out allergen controls as a category of preventive controls that must address food allergen cross-contact and proper labeling. A label control is, by definition, a preventive control under federal regulation.

Citation hook: Under 21 CFR §117.135(c)(2), allergen labeling is explicitly classified as a preventive control, meaning any label-related allergen failure is simultaneously a labeling violation and a HARPC program failure — two distinct categories of regulatory non-compliance.

How Allergen Labeling Failures Happen: A Root Cause Framework

Understanding the failure mode is essential for prevention. The following table maps common allergen labeling failure modes to their regulatory root causes and the preventive controls that should have caught them.

Practical Compliance Guidance: Six Controls You Should Implement Now

1. Build an Allergen-Specific Label Review Into Your Change Control SOP

Every formulation change — even a minor ingredient substitution — must trigger a mandatory allergen review before the change is approved. This review should be documented, signed off by a qualified individual (as defined in §117.180), and filed as a record under §117.190. The Schreiber Foods scenario illustrates why this step cannot be informal or assumed.

2. Implement Line Clearance and Label Verification Procedures

Before any production run begins, your packaging SOP should require a documented line clearance that includes label identity verification. Verify that: - The label on the line matches the product being produced - The label version is current and approved - The allergen declarations on the label match the current formulation

This verification should be a monitoring activity under §117.145, performed by a trained employee and documented at each production run.

3. Conduct an Annual Allergen Hazard Analysis Review

Your hazard analysis is not a one-time document. Under §117.170, you must reanalyze your food safety plan whenever there is a significant change in the activities conducted at your facility, and at least every three years. Build an annual allergen-specific review into your calendar that evaluates: - All intentional allergen-containing ingredients and whether they are correctly declared - Any new allergen cross-contact risks introduced by facility changes or new products - Supplier ingredient specifications for potential hidden allergens (e.g., "natural flavors" derived from allergenic sources)

4. Establish a Label Version Control System Integrated With Your Document Control Program

Labels are controlled documents. If your facility does not manage label versions with the same rigor as your SOPs — unique version numbers, effective dates, superseded versions archived — you have a gap that could produce exactly the kind of failure seen in this recall. Your document control SOP (a required element under §117.190) should explicitly cover labels.

5. Train Employees on Allergen Awareness Annually — And Document It

§117.4 requires that all individuals engaged in manufacturing, processing, packing, or holding food be qualified to perform their assigned duties. For employees involved in labeling, packaging, or formulation, this qualification must include allergen awareness training. Document training completion, and make refresher training mandatory when any allergen-related change is made to a product or process.

6. Verify Your Sesame Compliance Now — FASTER Act Enforcement Is Active

If you have not yet added sesame to your allergen labeling and preventive controls program, this is an immediate compliance action item. The FASTER Act's sesame provisions became effective January 1, 2023, and FDA has been clear that it expects full compliance. Any product containing sesame without proper label declaration is currently subject to recall and enforcement action.

What FDA Will Look For During a Post-Recall Inspection

If a facility issues a recall for undeclared allergens, FDA will almost certainly conduct a follow-up inspection. Based on FDA's published inspection approach and Warning Letter history, inspectors will focus on:

• The food safety plan: Is the allergen hazard identified? Is there a documented preventive control?
• Monitoring records: Is there documented evidence that label controls were being actively monitored?
• Corrective action records: When previous labeling discrepancies were found, was there a documented corrective action and root cause analysis?
• Training records: Were employees performing label-related tasks qualified under §117.4?
• Change control records: Was there a documented process for managing formulation and label changes?

The absence of any of these records — not just the failure itself — is independently citable as a violation.

Citation hook: FDA post-recall inspections for undeclared allergen events routinely result in Form 483 observations or Warning Letters citing failures in preventive controls monitoring, records maintenance, and qualified individual oversight — meaning the recall itself is often the least of a facility's regulatory problems.

The Business Case for Proactive Allergen Compliance

Beyond regulatory exposure, the cost of an undeclared allergen recall is substantial. Industry data suggests that the average direct cost of a food recall exceeds $10 million when factoring in product retrieval, disposal, consumer notification, legal fees, and reputational damage. For smaller manufacturers, a single recall can be existential.

The 144 cases involved in the Schreiber Foods recall may seem like a small volume, but the regulatory exposure, reputational impact, and required corrective actions are disproportionate to the quantity involved. FDA does not scale its enforcement expectations to batch size.

A well-structured allergen preventive controls program — built on a thorough hazard analysis, documented label controls, effective training, and rigorous records — costs a fraction of a single recall and eliminates the risk entirely.

How Certify Consulting Can Help

At Certify Consulting, I work with food manufacturers across the FDA-regulated industry to build allergen control programs that pass FDA inspection the first time. With over 200 clients served and a 100% first-time audit pass rate, I understand exactly what FDA inspectors look for — and what gaps put facilities at risk.

Whether your facility needs a gap assessment against 21 CFR Part 117, a food safety plan reanalysis, or hands-on support building your allergen preventive controls program, I can help you get there efficiently and defensibly.

Learn more about our GMP consulting services for food manufacturers or visit certify.consulting to schedule a consultation.

Frequently Asked Questions

What regulation requires allergen labeling on food products?

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires that the nine major food allergens — milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, and sesame (added by the FASTER Act effective January 1, 2023) — be declared on food labels. Violations are enforceable by FDA and can result in mandatory recall.

Is allergen labeling covered under 21 CFR Part 117?

Yes. Under 21 CFR §117.135(c)(2), allergen controls — including proper labeling — are explicitly classified as preventive controls. Facilities subject to the Preventive Controls for Human Food rule must include allergen labeling as a documented preventive control in their food safety plan.

What is the most common cause of undeclared allergen recalls?

Labeling and packaging control failures are the most common root cause, including wrong label application, outdated label versions, and formulation changes that were not reflected in updated labels. These failures point to gaps in preventive controls monitoring and document/change control systems.

When did sesame become a required allergen declaration?

Sesame was added as the ninth major food allergen under the FASTER Act of 2021, with an effective compliance date of January 1, 2023. All food products containing sesame must now declare it on the label, and manufacturers must include sesame in their allergen preventive controls programs.

What happens to a food facility after an undeclared allergen recall?

FDA typically conducts a follow-up inspection to assess whether the facility's food safety plan adequately addresses allergen hazards. Inspectors review monitoring records, corrective action documentation, training records, and change control procedures. Deficiencies can result in FDA Form 483 observations, Warning Letters, or — in serious cases — injunctions or consent decrees.

Last updated: 2026-04-08

Source: FDA Safety Alert — Schreiber Foods, Inc. Issues Allergy Alert on Undeclared Tree Nuts (Almonds)