Undeclared Allergens in Fermented Foods: What Prevents FDA Recalls

Allergen labeling failures are one of the most preventable categories of FDA food recalls — and one of the most recurring. A recent enforcement action involving "…And Kimchi" branded sliced kimchi, manufactured by Ocinet, Inc. of Downey, California, illustrates exactly how these failures happen and, more importantly, what a functioning quality system would have caught before a single unit reached a consumer.

The product — sliced kimchi sold under UPCs 8541200408, 8541200409, and 8541200411 — was recalled because it contained undeclared fish (anchovies). Under 21 CFR Part 101, fish is a major food allergen. Failing to declare it on the label is not a technicality. For the roughly 1% of Americans with a fish allergy, an undeclared exposure can trigger anaphylaxis, a life-threatening reaction that requires immediate medical intervention.

This article isn't about Ocinet. It's about the system gaps that allow this class of error to reach the market in the first place — and the controls that reliably prevent it.

Why Undeclared Allergen Recalls Keep Happening

The FDA has tracked undeclared allergens as a leading cause of food recalls for over a decade. According to FDA enforcement data, allergen-related recalls consistently account for roughly 40% of all Class I food recalls — the most serious category, where there is a reasonable probability of serious adverse health consequences or death.

Fermented and traditionally prepared foods like kimchi carry a particular risk profile. Many of these products use complex ingredient blends where fish pastes, sauces, or powders function as flavor enhancers rather than primary ingredients. Anchovies and anchovy paste, for instance, are common kimchi components but may be sourced through a supplier that changes formulations, relabels intermediate products, or provides ingredients under names that don't clearly signal their allergenic content.

The gap usually isn't malicious. It's a system that wasn't designed to catch the failure mode.

The Regulatory Framework: What 21 CFR Part 101 and FSMA Actually Require

Before getting into controls, it's worth being precise about what the law demands — because there's still meaningful confusion in the small and mid-size food manufacturer space.

Major Food Allergens Under FALCPA

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established nine major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (sesame was added by the FASTER Act, effective January 1, 2023). Fish, as a category, must be declared by common name — so "anchovies" must appear either in the ingredient list or in a "Contains: Fish (Anchovies)" statement.

This is codified at 21 CFR § 101.4 (ingredient labeling) and § 101.91 (food allergen labeling requirements). There is no grace period for a known allergen in a finished formulation. If the ingredient is in the product, the label must say so.

FSMA Preventive Controls: The Missing Layer

The Food Safety Modernization Act's Preventive Controls for Human Food rule (21 CFR Part 117), finalized in 2015, went further. It doesn't just require allergen labeling — it requires manufacturers to have a written Food Safety Plan that specifically identifies allergen cross-contact and undeclared allergens as hazards, and to have documented preventive controls in place to address those hazards.

Under 21 CFR § 117.135, allergen controls are explicitly listed as one of the required categories of preventive controls. Under § 117.140, manufacturers must validate that those controls are effective. Under § 117.145, they must monitor the controls. Under § 117.150, they must take corrective actions when monitoring reveals a deviation.

In plain terms: it's not enough to have the right label. You need a documented system that verifiably ensures the right label is always on the right product with the right formulation behind it. That's a quality system problem, not just a labeling problem.

What a Functioning Quality System Would Have Caught

Here is where prevention lives. When I work with food manufacturers on FSMA compliance and allergen program development, I find that undeclared allergen failures almost always trace back to one or more of the following gaps. Each one is preventable with deliberate system design.

1. Supplier Ingredient Verification

The most common root cause of undeclared allergens is an upstream change that the manufacturer never captured. A supplier reformulates a paste. A new vendor uses a different anchovy-based flavor carrier under a generic trade name. An intermediate ingredient gets relabeled at a co-packer without allergen disclosure.

A robust Supplier Verification Program — required under 21 CFR § 117.405 as part of the FSMA Supply Chain Program — should include:

• Allergen-specific Certificates of Analysis (COAs) for every ingredient lot, with explicit allergen declarations
• Supplier questionnaires that require disclosure of any formulation changes and any shared-equipment allergen risks
• Periodic supplier audits or third-party audit verification, with allergen controls as a specific audit scope item
• Ingredient specification sheets that are reviewed and updated at defined intervals, not just at onboarding

The question a quality system needs to answer is: "If my anchovy paste supplier changes their production process tomorrow, will I know before that ingredient enters my product?" If the answer is "we'd find out eventually," the system isn't working.

2. Formulation Change Control

Undeclared allergens also show up when the recipe changes internally — a new batch, a reformulation, a cost-reduction substitution — and the label doesn't keep pace. This is a change control failure.

A documented change control procedure should require that any ingredient substitution or formulation modification triggers an automatic review of the allergen profile and a mandatory label reconciliation before the new formulation is released to production. This isn't bureaucracy for its own sake. It's the mechanism that catches a decision made in the kitchen or the purchasing department before it creates a labeling violation on the shelf.

I've seen this happen in well-intentioned operations where a production manager substituted an ingredient during a supply shortage, assuming the swap was equivalent, without understanding that the replacement product contained fish. By the time the error surfaced, thousands of units were in distribution.

3. Label Review and Reconciliation

Label review in many small food operations is informal — someone looks at the label, confirms it looks right, and moves on. That process is not adequate for allergen control.

A formal label reconciliation process should verify, for every production run:

• The label in use corresponds to the current approved formulation version
• The ingredient list reflects the actual lot of ingredients used in that run
• Every major allergen present in the formulation appears in the ingredient list or a "Contains" statement in the required format

This review should be documented, with a signature and date, and it should be performed by someone who understands both the formulation and the regulatory requirements — not just whoever is near the printer.

4. Allergen Risk Assessment in the Hazard Analysis

Under 21 CFR § 117.130, every registered food facility that falls under FSMA's Preventive Controls rule is required to conduct a hazard analysis for their products and processes. Undeclared allergens — specifically allergens that may be present due to formulation, cross-contact, or labeling error — must appear as identified hazards where the hazard analysis determines they are reasonably foreseeable.

What I find in practice is that many small manufacturers either haven't done a formal hazard analysis at all, or they have a document that was completed once and never updated to reflect changes in suppliers, ingredients, or production processes. A hazard analysis is a living document. If your supplier list changed six months ago and your hazard analysis hasn't, the analysis is wrong.

5. Finished Product Label Audits

Even with all the upstream controls in place, a periodic finished product audit — pulling labeled units from production and verifying that the declared ingredients match the actual formulation — provides an important last-check signal. This doesn't need to be resource-intensive. A structured monthly review of a statistically selected sample of finished product labels, cross-referenced against current formulation records, will catch drift before it reaches a recall.

The Role of Fermented Food Complexity

Kimchi and other fermented foods deserve specific attention here because they sit at an intersection of traditional preparation methods and modern food safety regulation. The ingredients in a traditional kimchi formulation — fish paste, fish sauce, dried shrimp, fermented seafood condiments — are often multi-component, often sourced from suppliers with variable labeling practices, and often carry hidden allergen risk that isn't apparent from a casual review of the ingredient name.

Fish paste labeled under a Korean-language trade name may not immediately communicate its allergen content to an English-speaking quality manager reviewing a COA. Anchovy-based products are sometimes listed under ingredient names that do not include the word "anchovy" or "fish" at all. This is exactly the kind of gap that a well-designed allergen control program — one that digs into ingredient composition rather than relying on label surface review — is designed to catch.

If you manufacture fermented foods with complex ingredient blends, in my view your allergen program needs to include ingredient-level deep dives that go beyond face-value label review. Ask your suppliers: what is in this? Is any component derived from a major allergen? Get it in writing.

What FDA Expects to See During an Inspection

FDA investigators examining an undeclared allergen situation will look at several specific areas of your Food Safety Plan and production records. Knowing what they're looking for is useful for building a system that will hold up.

A single gap in this table is addressable. Multiple gaps in this table is a recall waiting to happen — or an FDA warning letter, or both.

Practical Steps for Food Manufacturers Right Now

If you manufacture a food product that contains any of the nine major allergens — or that uses ingredients that could contain allergens through cross-contact or complex sourcing — here is where to start:

Step 1: Audit your ingredient inventory against your current labels. Pull every ingredient currently in use. Cross-reference against the allergen declarations on your current approved labels. Any mismatch is a priority finding.

Step 2: Contact your suppliers. Request updated allergen attestations for all current ingredient lots. Don't rely on documentation from onboarding if that was more than 12 months ago.

Step 3: Review your hazard analysis. If you have one, verify that undeclared allergens appear as identified hazards. If you don't have one, that's your starting point — FSMA requires it for most registered facilities.

Step 4: Document your label review process. Even if your process is currently informal, write it down, build in the allergen cross-check step, and start generating records. In an FDA inspection, if it isn't documented, it didn't happen.

Step 5: Build a change control trigger for ingredients. Any new ingredient or reformulation should require a label review and allergen sign-off before production.

None of these steps require a large compliance budget. They require attention and documentation. The manufacturers who avoid allergen recalls aren't necessarily bigger or better-resourced than those who don't — they just built systems that catch errors before they ship.

A Note on Small Manufacturers and FSMA Applicability

One question I hear often: "Does FSMA Preventive Controls apply to me?" The answer depends on your facility's annual food sales and whether you qualify as a Very Small Business (under $1 million in total annual sales of human food) or a Small Business (fewer than 500 full-time equivalent employees). Very Small Businesses had a compliance date of September 17, 2018, for Preventive Controls. The allergen labeling requirements under FALCPA apply regardless of business size.

If your operation falls below the FSMA Preventive Controls threshold, FALCPA still governs your labels. And in my view, the FSMA framework for allergen controls is worth implementing anyway — not because FDA requires it, but because it works. A written hazard analysis and documented controls protect your customers and your business.

The Bigger Picture

Allergen recalls are not random. They are the predictable output of a system that didn't have the right controls in place. Every undeclared allergen recall I've seen — and working with 200+ food, pharma, and consumer product clients over the past eight-plus years, I've seen more than a few — traces back to a gap in one of the categories above.

The good news is that these are all solvable problems. The ingredients for a functioning allergen control program are not exotic: a written hazard analysis, documented supplier verification, formal change control, label reconciliation records, and periodic audits. That's the system. When it's working, undeclared allergens don't reach consumers.

The Ocinet recall is a useful case study because it's not an unusual story. It's a common one. And common problems have known solutions.

If you're a food manufacturer with questions about building or auditing your allergen control program, or if you're preparing for an FDA inspection and want to know where your gaps are, reach out to Certify Consulting. We've helped manufacturers across food, dietary supplement, and pharmaceutical categories build the systems that keep products on shelves and out of enforcement actions.

You can also review our FDA food compliance resources for additional guidance on FSMA implementation and allergen program development.

Source: FDA Enforcement Action — Ocinet, Inc. recall of "…And Kimchi" branded sliced kimchi (UPCs 8541200408, 8541200409, 8541200411) for undeclared fish (anchovies). Full recall notice available at FDA.gov.

Regulatory references: 21 CFR Part 101 (food labeling); 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food); FALCPA (Pub. L. 108-282); FASTER Act of 2021 (sesame effective January 1, 2023).

Last updated: 2026-05-16