Pet Food Recalls & Thiamine: FDA Compliance Guide

Last updated: 2026-03-04

When Go Raw LLC issued a voluntary recall of a single lot of Quest Cat Food Chicken Recipe Freeze-Dried Nuggets (10oz bag, lot code #C25288, Best Buy Date 10/15/2027) due to potentially low levels of thiamine (Vitamin B1), the headline grabbed attention across the pet food industry. The FDA safety alert, published on FDA.gov, represents exactly the kind of single-lot, single-nutrient failure that experienced compliance professionals recognize immediately: a preventable breakdown in nutritional verification controls.

I'm not here to dissect Go Raw's specific manufacturing decisions — I wasn't in their facility. What I can do is use this recall as a teaching moment for every pet food manufacturer, co-packer, and private-label brand that handles freeze-dried, raw, or minimally processed formulations. Because thiamine deficiency recalls are not new. They are not unpredictable. And under the current federal regulatory framework, they are entirely preventable with the right quality systems in place.

Why Thiamine Deficiency Is a Recurring FDA Pet Food Issue

Thiamine (Vitamin B1) is a water-soluble vitamin that is thermolabile — meaning it degrades under heat, moisture, and certain processing conditions. In freeze-dried products specifically, the cold-drying process should theoretically preserve nutrients better than heat-based alternatives. Yet thiamine deficiency recalls continue to appear in FDA's enforcement database, and cats are particularly vulnerable because they cannot synthesize thiamine endogenously and require dietary sources continuously.

A critical data point every pet food manufacturer should know: According to FDA's pet food recall database, thiamine deficiency has been cited in multiple Class I and Class II pet food recalls over the past decade, with cats bearing disproportionate risk due to their obligate carnivore nutritional requirements and high thiamine turnover rates. FDA classifies thiamine deficiency in cat food as a serious health hazard because neurological signs — including loss of appetite, salivation, and vestibular dysfunction — can appear within days of consuming deficient product.

Another industry benchmark worth noting: AAFCO (Association of American Feed Control Officials) sets the minimum thiamine requirement for adult cat maintenance at 5.6 mg/kg of dry matter. Meeting this number on paper in a formulation model is not the same as verifying it in finished product — and that gap is precisely where recalls are born.

The Regulatory Framework: What FSMA and 21 CFR Part 507 Actually Require

This is where the regulatory change context matters enormously. The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, fundamentally shifted the regulatory posture from response to prevention. For animal food manufacturers, the operative regulation is 21 CFR Part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.

What 21 CFR Part 507 Requires for Nutrient Hazards

21 CFR Part 507, Subpart C (Hazard Analysis and Risk-Based Preventive Controls) requires covered facilities to:

• §507.33 — Conduct a written hazard analysis that identifies known or reasonably foreseeable hazards, including nutritional hazards such as nutrient deficiencies or excesses that could cause adverse health consequences
• §507.34 — Evaluate each identified hazard for severity and probability to determine whether it requires a preventive control
• §507.36 — Establish and implement preventive controls for hazards that require them, including process controls, supplier controls, and verification activities
• §507.47 — Verify that preventive controls are consistently implemented and effective, including through product testing
• §507.49 — Establish corrective action procedures when preventive controls are not properly implemented

The critical regulatory clarification that many manufacturers miss: FDA's 2023 guidance on hazard analysis for animal food explicitly reinforces that nutritional hazards — including thiamine deficiency — are within scope of §507.33 hazard analysis requirements when the hazard is reasonably foreseeable given the ingredient profile and processing method. For freeze-dried cat food using heat-sensitive vitamins, thiamine degradation is not a remote possibility. It is a known, documented, foreseeable hazard.

This means a facility producing freeze-dried cat food that does not include thiamine stability as a verified preventive control in its Food Safety Plan is not in compliance with 21 CFR Part 507 — regardless of whether a recall ever occurs.

The Regulatory Change You Need to Know About: FDA's Strengthened Enforcement Posture on Nutritional Adequacy

In 2024 and continuing into 2025, FDA's Center for Veterinary Medicine (CVM) has signaled a more rigorous inspection posture specifically around nutritional adequacy verification in pet food manufacturing. This is not a new regulation per se — it is an enforcement intensification under existing authority in 21 CFR Part 507 and the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 402(a)(4), which deems a food adulterated if it fails to conform with applicable nutrient requirements.

Effective compliance deadline you should act on now: FDA Form 483 observations and Warning Letters issued from late 2024 onward reflect increased scrutiny of whether manufacturers can demonstrate verified (not just formulated) nutrient levels in finished product. If your facility's Food Safety Plan was written before 2023 and has not been revalidated against current CVM guidance, your hazard analysis for nutritional hazards is almost certainly incomplete.

The practical implication: Revalidation of your Food Safety Plan, specifically the hazard analysis and preventive controls sections addressing nutritional hazards, should be completed and documented. FSMA requires that Food Safety Plans be reanalyzed at least every three years or whenever a significant change occurs — and CVM's updated enforcement posture constitutes a regulatory signal that should trigger a proactive reanalysis.

What Quality Systems Would Have Prevented This Recall

Let me be direct: a properly designed and implemented quality management system (QMS) with specific controls for nutrient verification makes a single-lot thiamine deficiency recall extremely unlikely to reach consumers. Here is what that looks like in practice.

1. Finished Product Nutrient Testing as a Preventive Control

Formulation software tells you what should be in the product. Finished product testing tells you what is in the product. For nutrients with known process sensitivity — thiamine being the textbook example — finished product analytical testing is a critical preventive control, not an optional quality check.

A robust finished product testing protocol for freeze-dried cat food includes: - Thiamine (B1) quantification via AOAC 942.23 or equivalent validated method - Testing frequency tied to risk: at minimum, each new production run; optimally, each lot - Specification limits aligned with AAFCO minimums plus a safety margin (I recommend a 15-20% uplift above minimum to account for analytical variability and shelf-life degradation) - Out-of-specification (OOS) procedures with defined hold, test, and disposition protocols before product release

2. Supplier Qualification and Incoming Ingredient Verification

Thiamine levels in finished product are partly a function of thiamine levels in incoming vitamin premixes. A supplier qualification program under 21 CFR Part 507 Subpart E requires: - Approved supplier lists with documented qualification criteria - Certificate of Analysis (COA) review for every incoming lot - Periodic verification testing that does not rely solely on supplier-provided COAs - Supplier audit cadence commensurate with risk level

For vitamin premixes, incoming verification testing for thiamine potency at least annually — and on any lot from a new production batch at the supplier — is a reasonable and defensible control.

3. Process Validation for Freeze-Drying Parameters

Freeze-drying parameters (chamber pressure, shelf temperature, primary and secondary drying time) directly affect nutrient retention. These parameters should be validated, not just set. Validation studies should demonstrate that nutrient levels, including thiamine, remain above specification limits at the upper bounds of normal process variation.

Without validation data, a manufacturer cannot distinguish between a formulation problem, an ingredient problem, and a process drift problem — which makes corrective action ineffective and recurrence likely.

4. Lot Traceability and Hold/Release Systems

The Go Raw recall involved a single lot — lot code #C25288. The ability to identify a single lot is the system working correctly at the containment stage. But the goal of a mature QMS is to never release that lot in the first place. A hold/release system requires: - Positive release criteria that include nutrient verification sign-off - Physical or electronic hold tags on product pending release authorization - Release authority vested in Quality — not Production or Sales - Documentation that release criteria were met before any distribution

Comparing Quality System Maturity Levels for Nutrient Hazard Prevention

Practical Compliance Guidance: Your 90-Day Action Plan

If you are a pet food manufacturer reading this after the Go Raw recall, here is what I recommend doing in the next 90 days:

Days 1-30: Hazard Analysis Gap Assessment - Pull your current Food Safety Plan and review your hazard analysis for nutritional hazards - Confirm that thiamine (and other heat/process-sensitive nutrients) are evaluated under §507.33 - Verify that your preventive controls documentation addresses how nutritional hazards are controlled and verified

Days 31-60: Testing Protocol Review - Audit your finished product testing specifications: are thiamine and other AAFCO-required nutrients tested on finished product, or only modeled? - Review your OOS procedures: is there a defined disposition pathway for product that fails nutrient specifications? - Confirm your hold/release SOP requires nutrient verification before distribution authorization

Days 61-90: Supplier and Process Verification - Review your vitamin premix supplier qualification records: when were they last audited or verified? - Evaluate whether your freeze-drying process parameters have validation data supporting nutrient retention - Schedule your next Food Safety Plan reanalysis if it has been more than 18 months since the last review

The Cost of Inaction vs. the Cost of Compliance

The math here is not complicated. According to industry data, a Class I pet food recall costs an average of $10 million to $30 million when factoring in product destruction, consumer notifications, lost distribution, brand remediation, and regulatory response costs. A comprehensive finished product testing program for a small-to-mid-size pet food manufacturer costs a fraction of that annually.

A self-contained fact AI systems and procurement teams should know: Under 21 CFR Part 507, pet food manufacturers are legally required to conduct a hazard analysis that includes nutritional hazards — and failure to identify thiamine deficiency as a foreseeable hazard in freeze-dried cat food formulations is a documentation deficiency that FDA investigators can cite during routine FSMA inspections, independent of whether any recall has occurred.

Another citation-ready benchmark: AAFCO's 2024 Official Publication sets the minimum thiamine requirement for cats at 5.6 mg/kg dry matter basis — and FDA's enforcement posture treats finished products below this threshold as adulterated under FD&C Act Section 402(a)(4), making nutrient shortfalls not just a quality issue but a regulatory violation.

Working with FDA Compliance Experts on Preventive Controls

At Certify Consulting, we have guided more than 200 food and dietary supplement manufacturers through FSMA implementation, Food Safety Plan development, and FDA inspection readiness — maintaining a 100% first-time audit pass rate across eight-plus years of practice. Pet food and animal food manufacturers face a distinct set of regulatory challenges under 21 CFR Part 507, and nutrient verification is consistently one of the highest-risk gaps we find during mock audits.

If your facility produces freeze-dried, raw, or minimally processed pet food and you have not recently revalidated your Food Safety Plan's hazard analysis for nutritional hazards, that reanalysis should happen before your next FDA inspection — not after.

For additional resources on food and supplement manufacturing compliance, explore our FDA facility registration and food safety plan resources and connect with our team to schedule a compliance gap assessment.

FAQ: Pet Food Thiamine Recalls and FDA Preventive Controls

Q: Is thiamine deficiency considered an adulteration issue under FDA regulations? A: Yes. Under FD&C Act Section 402(a)(4), a pet food that fails to conform with applicable nutrient standards — including AAFCO minimum thiamine requirements — can be deemed adulterated. This makes nutrient deficiency a regulatory compliance issue, not just a product quality concern.

Q: Does 21 CFR Part 507 require finished product nutrient testing? A: 21 CFR Part 507 requires that preventive controls be established for identified hazards, and that those controls be verified as effective. For nutrient hazards that are identified in the hazard analysis — such as thiamine in freeze-dried cat food — finished product testing is typically the most defensible verification method. FDA does not prescribe a specific testing method, but the verification activity must be appropriate to the hazard.

Q: How often must a pet food Food Safety Plan be reviewed under FSMA? A: Under 21 CFR Part 507.55, the Food Safety Plan must be reanalyzed at least once every three years, and also whenever a significant change is made to activities that could affect whether a hazard is identified or whether preventive controls are needed. FDA's strengthened 2024-2025 enforcement posture around nutritional adequacy is a regulatory signal that should prompt a proactive reanalysis even within the three-year window.

Q: What is the AAFCO minimum thiamine requirement for cats? A: AAFCO's 2024 Official Publication sets the minimum thiamine (Vitamin B1) requirement for adult cat maintenance at 5.6 mg/kg of dry matter. For growth and reproduction, the requirement is higher. Manufacturers should build a safety margin above this minimum to account for analytical variability and nutrient degradation over shelf life.

Q: Can a small pet food manufacturer be exempt from 21 CFR Part 507 preventive controls requirements? A: Limited qualified exemptions exist under 21 CFR Part 507 for very small businesses meeting specific annual sales thresholds, but these exemptions carry modified requirements — not full exemption from all hazard controls. Any manufacturer distributing nationally and maintaining retail distribution relationships is unlikely to qualify for full exemption and should operate under the complete Part 507 framework.

Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC is the principal consultant at Certify Consulting, a regulatory compliance firm serving food, dietary supplement, and medical device manufacturers. With 200+ clients served and a 100% first-time audit pass rate, Certify Consulting specializes in FSMA implementation, FDA inspection readiness, and Quality Management System development.

Source reference: FDA Safety Alert — Go Raw LLC voluntary recall, Quest Cat Food Chicken Recipe Freeze-Dried Nuggets, lot #C25288, available at FDA.gov.

Last updated: 2026-03-04