Pet Food Thiamine Deficiency: Preventing FDA Recalls

In February 2026, Go Raw LLC of Cottonwood Heights, Utah issued an expanding voluntary recall of its Quest Diet Cat Food products due to potentially low levels of thiamine (Vitamin B1) — first announced February 17, 2026, and expanded February 26, 2026, to include two additional lots of frozen chicken recipe products. The FDA recall notice is publicly available at FDA.gov and serves as a timely reminder of a failure mode that is entirely preventable.

I'm not here to analyze that specific recall. What I want to do is use it as a teachable moment: every thiamine deficiency recall in pet food history points back to the same root causes — inadequate raw material verification, insufficient in-process nutrient monitoring, and quality management systems that weren't designed to catch micronutrient variance before product ships.

If you're a pet food manufacturer, contract manufacturer, private label brand, or ingredient supplier, this article is your prevention roadmap.

Why Thiamine (Vitamin B1) Is a Recurring Pet Food Recall Driver

Thiamine deficiency is not a new problem in pet food. The FDA has documented multiple thiamine-related recalls over the past decade, and the pattern is consistent: freeze-dried, frozen raw, and thermally processed wet foods are the most frequently affected formats.

Here's why thiamine is uniquely vulnerable:

• Thiamine is heat-labile. It degrades rapidly above 100°C, making thermal processing a significant destruction pathway.
• Thiamine is water-soluble. It can leach out during blanching, washing, or moisture-heavy processing steps.
• Thiamine antagonists exist naturally in some raw ingredients. Raw fish, certain shellfish, and some plants contain thiaminase enzymes that actively destroy thiamine.
• Freeze-drying doesn't protect thiamine from pre-process degradation. If raw materials arrive with compromised thiamine levels, freeze-drying locks in the deficiency.

For cats specifically, thiamine deficiency is a serious veterinary emergency. Cats cannot synthesize thiamine endogenously and require a continuous dietary source. According to the Association of American Feed Control Officials (AAFCO), the minimum thiamine requirement for adult cat maintenance is 5.6 mg/kg on a dry matter basis — a threshold that must be verifiably met in every production lot.

A 2023 FDA Center for Veterinary Medicine (CVM) analysis found that nutritional inadequacy — including vitamin and mineral deficiencies — represents one of the top five root cause categories in voluntary pet food recalls. Thiamine deficiency alone has triggered recalls affecting millions of units across brands large and small.

The Regulatory Framework You Must Understand

21 CFR Part 507: The Governing Regulation for Pet Food Safety

The foundational regulation governing pet food safety for most manufacturers is 21 CFR Part 507 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, which became fully effective for large businesses in September 2017 and for small businesses by 2019.

Under 21 CFR Part 507, nutrient deficiency is explicitly recognized as a known or reasonably foreseeable hazard requiring a formal hazard analysis. Specifically:

• 21 CFR §507.33 requires a written hazard analysis identifying biological, chemical, and physical hazards — but also naturally occurring hazards and those introduced through process inadequacies.
• 21 CFR §507.34 requires preventive controls for hazards that are reasonably likely to occur absent such controls.
• 21 CFR §507.47 requires supplier verification activities including testing of raw materials when the supplier's process is a critical control point.
• 21 CFR §507.55 requires verification activities — including periodic testing of finished product — to confirm that preventive controls are effective.

The critical regulatory insight here is this: under 21 CFR Part 507, a manufacturer who ships product without verifying micronutrient levels against AAFCO or NRC minimums is in violation of the preventive controls requirement — not just ethically exposed, but legally non-compliant.

What Changed: 2024–2025 FDA Enforcement Shift

Beginning in late 2024, FDA's Center for Veterinary Medicine signaled a meaningful enforcement posture shift. CVM increased the frequency of import alerts, import refusals, and warning letters specifically citing inadequate preventive controls for nutritional hazards in pet food. This is a regulatory change manufacturers must act on now.

Practically, this means:

Effective Date Reminder: 21 CFR Part 507 is currently in force for all covered facilities. FDA's updated compliance guidance for nutritional hazards in animal food was communicated through CVM's industry guidance documents updated in 2024. Facilities that have not revisited their hazard analysis since original FSMA implementation should treat this as an immediate compliance gap.

The Four Quality System Failures Behind Every Thiamine Recall

After working with 200+ clients across food, supplement, and pharmaceutical manufacturing at Certify Consulting, I've seen thiamine and micronutrient recall scenarios reduce to four repeating system failures. Here they are — and here's what fixes each one.

Failure 1: Inadequate Raw Material Specification and Incoming Verification

What goes wrong: Vitamin premixes are accepted based solely on a supplier's Certificate of Analysis (COA) without independent verification testing. If the supplier's premix is under-potency, or if the wrong premix is used, the deficiency enters the process at the very first step.

Prevention protocol: - Write and enforce raw material specifications that include minimum acceptable thiamine potency with tolerance bands (e.g., thiamine mononitrate ≥ 98.5% purity, or vitamin premix meets label claim ± 5%). - Establish a supplier qualification program under 21 CFR §507.47 that requires initial qualification testing by an accredited third-party laboratory. - Implement skip-lot or periodic independent incoming testing — at minimum quarterly for high-frequency vitamin premix suppliers, and for every lot from new or provisionally qualified suppliers. - Maintain a vendor approved supplier list (ASL) with documented qualification status.

Failure 2: No In-Process Monitoring for Nutrient Degradation

What goes wrong: The premix is fine at receiving. But processing — thermal kill steps, moisture reduction, or extended hold times — destroys thiamine before the product is finished. No monitoring catches it.

Prevention protocol: - Conduct a process validation study specifically evaluating thiamine retention across your thermal process. This is a one-time investment that establishes your process parameters. - Define critical limits for time-temperature combinations that maintain thiamine above minimum levels, and document them in your HACCP or Preventive Controls plan. - For freeze-dried raw formats, validate that your raw material sourcing does not include thiaminase-containing ingredients without appropriate mitigation (pre-cooking, enzyme inactivation, or compensatory overage). - Consider overage formulation — adding thiamine at a level above the minimum to buffer against expected process losses. Industry standard practice is to calculate expected degradation and add a 10–25% overage depending on process severity.

Failure 3: Absent or Inadequate Finished Product Testing

What goes wrong: The manufacturer relies entirely on formulation calculations rather than analytical confirmation. Calculations assume 100% premix efficiency and no process loss — assumptions that real production never fully satisfies.

Prevention protocol: - Implement a finished product release testing program that includes proximate and micronutrient analysis. At minimum, test thiamine, taurine (for cat food), and any nutrient that is heat-sensitive or subject to process variability. - Use AOAC-accredited methods for thiamine analysis (AOAC 942.23 or equivalent) performed by an ISO/IEC 17025-accredited laboratory. - Establish a Certificate of Analysis (COA) release requirement — no lot ships without analytical confirmation of nutrient levels meeting specification. - Define out-of-specification (OOS) investigation procedures that include root cause analysis, corrective action, and retroactive lot review when a deficiency is found.

Failure 4: No Recall Readiness or Lot Traceability System

What goes wrong: When a deficiency is detected — whether internally or via customer complaint — the manufacturer cannot rapidly identify affected lots, quantities in distribution, or downstream customers. The result is delayed action, expanded harm, and regulatory exposure.

Prevention protocol: - Implement one-up, one-back traceability as required by 21 CFR §507.175 — the ability to identify the immediate previous source and immediate subsequent recipient of every lot. - Maintain batch records that link each finished lot to specific raw material lot numbers, manufacturing date, processing parameters, and finished product test results. - Maintain a distribution record system capable of generating a complete lot disposition report within two hours — a reasonable expectation during an FDA inspection or active recall. - Conduct an annual mock recall exercise and document the results.

Quality System Comparison: Minimum Compliance vs. Best Practice

Building the Right Testing Protocol: A Practical Checklist

For pet food manufacturers who want to operationalize micronutrient control right now, here is a practical implementation checklist aligned with 21 CFR Part 507 requirements:

Immediate Actions (0–30 days): - [ ] Review your hazard analysis to confirm thiamine and other heat-labile vitamins are listed as chemical/nutritional hazards - [ ] Pull your most recent finished product CoA and confirm thiamine was analytically tested (not calculated) - [ ] Verify your vitamin premix supplier is on your approved supplier list with documented qualification

Short-Term Actions (30–90 days): - [ ] Commission a process validation study for thermal processing steps affecting nutrient retention - [ ] Establish or update finished product specifications to include thiamine minimum with analytical method specified - [ ] Implement a lot release hold procedure pending receipt of finished product analytical results

Systemic Actions (90–180 days): - [ ] Conduct a gap assessment of your full 21 CFR Part 507 preventive controls program against current FDA enforcement expectations - [ ] Implement or upgrade your batch record and traceability system - [ ] Schedule and conduct a mock recall exercise; document findings and corrective actions

What a Strong Quality Management System Looks Like in Pet Food

The manufacturers who never appear on FDA recall lists share a common profile: they treat their quality management system as a revenue-protecting asset, not a compliance cost center.

At Certify Consulting, I've guided manufacturers through implementation of QMS frameworks that integrate 21 CFR Part 507 requirements with internationally recognized standards such as SQF (Safe Quality Food) Edition 9, ISO 22000:2018, and GFSI-benchmarked schemes — all of which include requirements for micronutrient hazard controls that go beyond FDA minimums.

The investment in a robust QMS — including qualified third-party consultation, laboratory partnerships, and staff training — is measured in tens of thousands of dollars. The cost of a multi-lot voluntary recall, including product retrieval, destruction, FDA communication, legal exposure, and brand damage, is measured in hundreds of thousands to millions of dollars.

The math has always favored prevention.

For manufacturers who want to benchmark their current state, our pet food compliance gap assessment identifies specific vulnerabilities in your preventive controls program — including micronutrient testing gaps — before an FDA inspector or a recall does.

Citation Hook Statements

"Under 21 CFR Part 507, nutrient deficiency in pet food is a legally recognized chemical hazard requiring documented preventive controls, supplier verification, and finished product testing — manufacturers who rely solely on formulation calculations for nutrient compliance are non-compliant with FDA's preventive controls rule."

"Thiamine deficiency in cat food is entirely preventable through three concurrent controls: incoming raw material potency verification, process validation for heat-labile nutrient retention, and 100% lot release testing with AOAC-accredited analytical methods."

"FDA's Center for Veterinary Medicine has increased enforcement scrutiny of nutritional hazard controls in pet food since 2024, making inadequate micronutrient testing protocols a material inspection risk for any covered facility under 21 CFR Part 507."

Frequently Asked Questions

What regulation governs thiamine testing requirements in pet food manufacturing?

21 CFR Part 507 — Preventive Controls for Animal Food — is the primary regulation. It requires manufacturers to conduct a hazard analysis identifying nutrient deficiency as a potential hazard, implement preventive controls (including testing protocols), and conduct verification activities confirming those controls are effective. AAFCO nutrient profiles establish the minimum nutrient levels that finished products must meet. Together, these create a legally enforceable framework for thiamine adequacy in commercial pet food.

How often should pet food manufacturers test finished products for thiamine?

At minimum, 21 CFR §507.55 requires periodic finished product testing as a verification activity. Best practice — and the standard I recommend to all Certify Consulting clients — is 100% lot release testing for any product where thiamine is a nutritionally critical nutrient (i.e., all cat food). For high-volume production, a statistical sampling plan using AOAC 942.23 or equivalent methods, with every lot represented, provides both regulatory defensibility and genuine product safety assurance.

Can a pet food manufacturer rely on a supplier's Certificate of Analysis instead of testing thiamine independently?

For initial qualification, a supplier CoA is a starting point — not a substitute for independent testing. 21 CFR §507.47 requires supplier verification activities that are appropriate to the risk posed by the raw material. A vitamin premix is a high-risk input because potency variance directly causes the end-use hazard. FDA expects periodic independent laboratory confirmation of premix potency, not perpetual reliance on supplier-generated data. A single off-spec premix lot accepted on CoA alone is the most common proximate cause of thiamine deficiency recalls.

What is the minimum thiamine requirement for cat food under AAFCO?

AACO's 2023 Official Publication specifies a minimum thiamine requirement of 5.6 mg/kg dry matter basis for adult cat maintenance, and a higher level for growth/reproduction diets. These are minimum levels — formulation should incorporate appropriate overage to account for process losses and analytical variance, typically 10–25% above the minimum depending on thermal process severity.

What should a pet food company do right now if they haven't reviewed their thiamine controls?

Start with a documented gap assessment of your current hazard analysis and preventive controls plan. Specifically: (1) Confirm thiamine is listed as a hazard with documented preventive controls; (2) Pull recent finished product test data and verify thiamine was analytically confirmed, not calculated; (3) Review your vitamin premix supplier qualification file for independent testing records; (4) If gaps exist, implement a corrective action plan with defined deadlines. If you need support, Certify Consulting offers focused regulatory gap assessments for pet food manufacturers — we've maintained a 100% first-time audit pass rate across 200+ clients.

The Bottom Line

The Go Raw LLC recall expansion in February 2026 is not an outlier — it is a data point in a documented pattern. Thiamine deficiency recalls happen when manufacturers lack the quality systems to catch micronutrient variance before it reaches consumers. That failure is predictable, preventable, and — under 21 CFR Part 507 — legally indefensible.

The standards, methods, and protocols to prevent thiamine deficiency recalls exist and are well-established. What separates companies that recall product from companies that don't is the consistent, documented application of those controls — not luck, not company size, and not product format.

If you're a pet food manufacturer who wants to close this gap, I'd encourage you to connect with us at Certify Consulting. Our team has guided manufacturers through 21 CFR Part 507 implementation, GFSI certification, and full QMS buildouts — and we've never had a client fail their first audit.

Prevent the recall. Protect the brand. Build the system that makes both possible.

Sources: FDA Recall Notice — Go Raw LLC Quest Diet Cat Food (FDA.gov, February 26, 2026); 21 CFR Part 507 (eCFR.gov); AAFCO Official Publication 2023; FDA CVM Compliance Programs; AOAC International Method 942.23.

Last updated: 2026-03-03