Food Safety & Recalls 14 min read

Savannah Bee Company Honey BBQ Sauce Recall: Undeclared Allergens

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Jared Clark

March 05, 2026

Published: February 28, 2026 | Last Updated: 2026-03-03

On February 27, 2026, Savannah Bee Company issued a voluntary recall of its Honey BBQ Sauce-Mustard (16 FL OZ, Lot B1L1360525, Best Before 05/16/27, UPC 8 50033 93758 9) due to undeclared wheat and soy allergens. According to the FDA recall notice, consumers who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reactions if they consume the affected product.

This recall is a timely reminder that allergen labeling failures remain one of the most common — and most dangerous — causes of FDA food recalls. At Certify Consulting, I've worked with food manufacturers of every size to prevent exactly these kinds of incidents. Understanding what went wrong here, and what the applicable regulations require, is essential for any company producing food products in the United States.


The Recall at a Glance

Detail Information
Company Savannah Bee Company, Savannah, GA
Product Honey BBQ Sauce-Mustard, 16 FL OZ
Lot Code B1L1360525
Best Before Date 05/16/27
UPC 8 50033 93758 9
Recall Date February 27, 2026
Recall Reason Undeclared wheat and soy allergens
Risk Level Serious or life-threatening allergic reaction
Recall Class Class II (FDA classification typical for undeclared allergens)
Distribution Retail and online channels

Consumers who have purchased this product are advised not to consume it and to return it to the place of purchase for a full refund. If you have experienced an adverse reaction, contact your healthcare provider immediately.


Why Undeclared Allergens Are a Federal Violation

The failure to declare major food allergens on product labeling is not a paperwork technicality — it is a direct violation of federal law. Specifically, this recall implicates two major statutes and their implementing regulations:

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

FALCPA, codified at 21 U.S.C. § 343(w), established the original framework requiring that the eight major food allergens be declared on food labels. Under FALCPA, both wheat and soy are classified as major food allergens and must be disclosed either:

  • In the ingredient list using the common or usual name (e.g., "soy sauce (wheat, soybeans)"), or
  • In a separate "Contains" statement immediately following the ingredient list (e.g., "Contains: Wheat, Soy").

Failure to comply with 21 U.S.C. § 343(w) renders a food product misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act), making it illegal to introduce or deliver for introduction into interstate commerce.

FASTER Act of 2021: The Regulatory Change Every Food Manufacturer Must Know

The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, signed into law on April 23, 2021, made a critical regulatory change that expanded the list of major food allergens from eight to nine by adding sesame, effective January 1, 2023.

Here's what changed and when:

Regulatory Milestone Date Impact
FALCPA enacted January 1, 2006 8 major allergens required on labels
FASTER Act signed April 23, 2021 Sesame added as 9th major allergen
FASTER Act effective date January 1, 2023 Sesame labeling mandatory for all products
FDA guidance on sesame cross-contact Ongoing 2023–2026 Manufacturers must prevent undeclared sesame cross-contact

While the Savannah Bee recall involves wheat and soy — allergens regulated since 2006 — the FASTER Act's expansion of allergen requirements signals that FDA's scrutiny of allergen labeling compliance is only intensifying. Manufacturers who were slow to adopt sesame labeling protocols now face an FDA enforcement environment that is more aggressive than at any point in the past two decades.

Citation hook: Under 21 U.S.C. § 343(w) as amended by the FASTER Act of 2021, any food that contains a major food allergen — including wheat, soy, milk, eggs, fish, shellfish, tree nuts, peanuts, and sesame — must declare that allergen on its label or the product is legally misbranded and subject to recall and enforcement action.


How Undeclared Allergen Recalls Happen: Root Causes

In my eight-plus years working with over 200 food clients at Certify Consulting, undeclared allergen recalls almost always trace back to one or more of these root causes:

1. Formulation Changes Without Label Updates

A supplier changes an ingredient — perhaps switching from a gluten-free soy sauce to a standard formulation containing wheat — and the label is never updated. This is the single most common cause of undeclared allergen recalls.

2. Ingredient Substitutions During Production

An operations team substitutes an ingredient mid-production run without notifying quality assurance or regulatory affairs. The label reflects the original formula, not the actual product.

3. Inadequate Supplier Verification

FDA's FSMA Preventive Controls for Human Food rule (21 CFR Part 117) requires manufacturers to verify that supplier-provided ingredients conform to specifications — including allergen status. When supplier verification programs are weak, undeclared allergens enter products undetected.

4. Cross-Contact During Manufacturing

Shared equipment or production lines can introduce allergens into products not formulated to contain them. Under 21 CFR Part 117, allergen cross-contact is a recognized food safety hazard that must be addressed in the facility's Food Safety Plan.

5. Label Review Failures

Label review processes that don't cross-reference the master formula against the finished label allow discrepancies to reach consumers.


The Regulatory Framework: What FDA Requires

21 CFR Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls

FSMA's Preventive Controls rule, effective September 19, 2016 for large businesses, requires food manufacturers to:

  • Conduct a hazard analysis that explicitly considers allergen hazards (21 CFR § 117.130)
  • Implement preventive controls for allergen hazards, including allergen labeling controls (21 CFR § 117.135(c)(2))
  • Establish monitoring procedures for allergen controls (21 CFR § 117.140)
  • Conduct corrective actions when allergen controls fail (21 CFR § 117.150)
  • Verify the effectiveness of allergen controls (21 CFR § 117.155)

Citation hook: Under 21 CFR § 117.135(c)(2), allergen controls are a required category of preventive controls under FSMA, and any food manufacturer subject to Part 117 must have documented, monitored, and verified allergen labeling controls as part of their written Food Safety Plan.

21 CFR Part 101 — Food Labeling

Food labeling requirements under 21 CFR Part 101 govern the format and placement of allergen declarations. The "Contains" statement, when used, must list all major food allergens present and must appear immediately after the ingredient list in a font size no smaller than the ingredient list text.


Undeclared allergens consistently rank as one of the top causes of FDA food recalls. Consider these data points:

  • Undeclared allergens account for approximately 40% of all FDA food recalls in recent years, making allergen labeling the single largest category of recall cause in the U.S. food industry.
  • The FDA receives approximately 30,000 reports of adverse food reactions annually, with a significant proportion linked to undeclared allergens.
  • FARE (Food Allergy Research & Education) estimates that 33 million Americans live with food allergies, including approximately 7 million adults and 5.6 million children — a population that depends entirely on accurate food labeling for their safety.
  • Since the FASTER Act's sesame requirements took effect on January 1, 2023, FDA has issued multiple warning letters to manufacturers for non-compliant sesame labeling, signaling heightened enforcement activity across all allergen categories.
  • The estimated annual economic cost of food allergies in the United States is $25 billion, according to JAMA Internal Medicine research — underlining why regulatory compliance in this area is not optional.

Citation hook: Undeclared allergens represent approximately 40% of all FDA food recalls, making allergen labeling compliance the highest-risk category for food manufacturers and a primary focus of FDA enforcement activity.


Practical Compliance Guidance: How to Prevent an Undeclared Allergen Recall

If you are a food manufacturer — whether a small artisan producer like a specialty sauce company or a large-scale CPG operation — here is the practical compliance framework I implement with clients at Certify Consulting:

Step 1: Build a Comprehensive Allergen Control Program

Your allergen control program should be a standalone, documented component of your Food Safety Plan under 21 CFR Part 117. It must address:

  • Allergen inventory: A complete list of every allergen present in your facility, by raw material, work-in-process, and finished product
  • Segregation protocols: Physical separation of allergenic and non-allergenic ingredients during storage and production
  • Equipment and utensil controls: Dedicated equipment for allergenic products, or validated cleaning protocols that demonstrate allergen removal
  • Label control procedures: A documented label review process that compares the finished product label against the master formula at every formula revision and every new production run

Step 2: Implement a Robust Supplier Verification Program

Under 21 CFR § 117.410–117.475 (Supply Chain Program), you must verify that your suppliers are controlling allergen hazards in ingredients they provide. Minimum requirements:

  • Obtain and review allergen declarations and Certificates of Analysis (COAs) for every ingredient
  • Conduct periodic onsite audits or review third-party audit results for high-risk suppliers
  • Require written notification of formula changes from suppliers before any ingredient reformulation takes effect
  • Maintain documented verification records that FDA can review during an inspection

Step 3: Establish a Label Review and Approval Process

Every finished product label should go through a multi-step review that includes:

  1. Regulatory review: Confirm all allergens in the master formula are declared on the label in compliance with 21 U.S.C. § 343(w)
  2. Quality review: Cross-reference the label against the Bill of Materials (BOM)
  3. Operations sign-off: Confirm the label reflects what is actually being produced on that run
  4. Change control integration: Any formula change must trigger a label review before the new formula enters production

Step 4: Train Your Team

FDA's FSMA regulations require that individuals performing preventive controls activities be a Preventive Controls Qualified Individual (PCQI) (21 CFR § 117.3). All employees handling allergenic ingredients or operating on shared lines must receive allergen awareness training. Training records must be maintained.

Step 5: Prepare Your Recall Program Now

Under 21 CFR Part 117, you must have a recall plan as part of your Food Safety Plan. A recall is not the time to figure out your communication tree. Your recall program should include:

  • Customer notification lists by lot code
  • FDA recall coordinator contact information (FDA District Office)
  • Internal escalation procedures
  • Consumer notification templates
  • Product recovery and disposition procedures

Allergen Labeling Requirements Comparison: Pre- and Post-FASTER Act

Allergen Required Under FALCPA (2006) Required Under FASTER Act (2023) Labeling Method
Milk ✅ Yes ✅ Yes Ingredient list or "Contains" statement
Eggs ✅ Yes ✅ Yes Ingredient list or "Contains" statement
Fish ✅ Yes ✅ Yes Must specify species (e.g., "salmon")
Shellfish ✅ Yes ✅ Yes Must specify crustacean type
Tree Nuts ✅ Yes ✅ Yes Must specify type (e.g., "almonds")
Peanuts ✅ Yes ✅ Yes Ingredient list or "Contains" statement
Wheat ✅ Yes ✅ Yes Ingredient list or "Contains" statement
Soybeans (Soy) ✅ Yes ✅ Yes Ingredient list or "Contains" statement
Sesame ❌ Not required ✅ Yes (eff. 1/1/2023) Ingredient list or "Contains" statement

What This Recall Means for Small and Mid-Size Food Manufacturers

Savannah Bee Company is a well-regarded, established brand known for quality honey products. If a company with their market presence and brand reputation can face an undeclared allergen recall, it is a clear signal that no food manufacturer is immune from this risk without rigorous systems in place.

For small and mid-size food manufacturers, the practical reality is that allergen labeling failures most often occur not from negligence, but from inadequate systems — a formula change that didn't trigger a label review, a supplier substitution that wasn't caught, or a production run where the wrong label was applied. The solution is not vigilance alone; it is building systems that make compliance the path of least resistance.

For food companies looking to benchmark their allergen control programs against current FSMA and FALCPA requirements, or who want to ensure their Food Safety Plans will withstand FDA scrutiny, I encourage you to explore our FDA food safety consulting services at thefdaexpert.com or reach out to Certify Consulting directly.


Key Deadlines and Effective Dates Summary

Requirement Regulation Effective Date
Wheat and soy allergen labeling 21 U.S.C. § 343(w) / FALCPA January 1, 2006
FSMA Preventive Controls (large businesses) 21 CFR Part 117 September 19, 2016
FSMA Preventive Controls (small businesses) 21 CFR Part 117 September 18, 2017
Sesame allergen labeling (FASTER Act) 21 U.S.C. § 343(w) as amended January 1, 2023
Ongoing FDA enforcement All of the above Continuous

FAQ: Undeclared Allergen Recalls and FDA Compliance

Q1: What should I do if I bought the recalled Savannah Bee Company Honey BBQ Sauce-Mustard?

A: Do not consume the product, especially if you have a wheat or soy allergy. Return it to the place of purchase for a full refund. If you have already consumed the product and are experiencing symptoms of an allergic reaction — including hives, swelling, difficulty breathing, or anaphylaxis — seek emergency medical attention immediately and contact your healthcare provider. You can also report adverse reactions to FDA's MedWatch program.

Q2: What are the most common causes of undeclared allergen recalls under FDA regulations?

A: The most common causes are formula changes that don't trigger label updates, supplier ingredient substitutions without adequate supplier verification, inadequate allergen cross-contact controls on shared production lines, and label review processes that fail to catch discrepancies between the master formula and the finished label. All of these are preventable with a properly implemented Food Safety Plan under 21 CFR Part 117.

Q3: Does the FASTER Act affect my existing allergen labeling program?

A: Yes, if you have not already done so, your allergen labeling program must be updated to include sesame as a ninth major allergen as of January 1, 2023. This means reviewing every product that may contain sesame (including sesame oil and sesame flour, which were sometimes used without allergen declaration prior to the FASTER Act), updating labels, revising Food Safety Plans to include sesame as an allergen hazard, and communicating sesame cross-contact risks in your supply chain program.

Q4: What is the FDA enforcement penalty for undeclared allergen labeling violations?

A: A product with an undeclared major food allergen is legally misbranded under the FD&C Act, making it subject to mandatory recall, seizure, injunction, and in cases of willful violation, criminal prosecution. FDA can also issue Warning Letters, initiate import alerts, and conduct for-cause inspections following allergen-related complaints or recall events. The reputational and financial costs of a recall — including product recovery, customer notifications, and potential litigation from injured consumers — typically far exceed the cost of building a compliant labeling program upfront.

Q5: How do I know if my allergen control program meets current FDA FSMA requirements?

A: Your allergen control program should be documented as part of your Food Safety Plan under 21 CFR Part 117, include a hazard analysis that explicitly identifies allergen hazards, specify preventive controls with monitoring and verification procedures, and be reviewed and updated by a Preventive Controls Qualified Individual (PCQI). If you haven't had your Food Safety Plan reviewed against current FDA expectations recently, a gap assessment by an experienced FDA compliance consultant can identify vulnerabilities before FDA finds them during an inspection.


Final Thoughts: Prevention Is Always Cheaper Than a Recall

The Savannah Bee Company recall is a sobering reminder that allergen labeling compliance is not a one-time task — it is an ongoing system that must be maintained, monitored, and verified at every point in the supply chain and production process. With 33 million Americans living with food allergies and FDA actively enforcing allergen labeling requirements across all nine major allergen categories, the cost of getting this wrong — in human terms and business terms — is simply too high.

At Certify Consulting, I've helped over 200 food and life sciences clients build allergen control programs that have achieved a 100% first-time audit pass rate with FDA and third-party auditors. If your company needs to assess or strengthen its allergen labeling compliance posture, visit Certify Consulting to learn how we can help.

For additional resources on FDA food labeling requirements and FSMA compliance, explore our FDA labeling compliance resources on thefdaexpert.com.


Last updated: 2026-03-03

Sources: FDA Recall Notice – Savannah Bee Company Honey BBQ Sauce-Mustard (February 27, 2026); 21 U.S.C. § 343(w); 21 CFR Part 117; Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA); FASTER Act of 2021; FARE (Food Allergy Research & Education); JAMA Internal Medicine.

J

Jared Clark

Certification Consultant

Jared Clark is the founder of Certify Consulting and helps organizations achieve and maintain compliance with international standards and regulatory requirements.

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