# FDA Recalls FixElixir Supplement Over Undeclared Kratom Compounds

> The FDA has issued a recall for FixElixir, a wellness supplement found to contain undisclosed mitragynine and mitragynine pseudoindoxyl from kratom. Consumers using the product face risks including respiratory depression, seizures, and dangerous drug interactions.

**Published:** 2026-05-31T16:40:17.772495+00:00 · **Author:** dietarysupplement.ai · **Category:** Safety

[Web version](https://dietarysupplement.ai/news/fda-recalls-fixelixir-supplement-over-undeclared-kratom-compounds-cf486c77/) · [中文](https://dietarysupplement.ai/zh/news/fda-recalls-fixelixir-supplement-over-undeclared-kratom-compounds-cf486c77/)

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FDA Recalls FixElixir Supplement Over Undeclared Kratom Compounds
The U.S. Food and Drug Administration has recalled FixElixir, an over-the-counter dietary supplement marketed for general wellness, after regulatory testing revealed the presence of undeclared kratom alkaloids—mitragynine and mitragynine pseudoindoxyl. [According to Newsweek's coverage of the FDA enforcement action](https://www.newsweek.com/fda-recall-weather-fix-elixir-kratom-1906497), the agency has warned consumers to stop using the product immediately due to risk of severe health effects including respiratory depression, seizures, and cardiac arrhythmias. The recall underscores a persistent problem: kratom-containing ingredients added to supplements without disclosure, leaving consumers unaware they are exposing themselves to opioid-receptor-active compounds.

## What Happened

FixElixir was distributed as an unlabeled wellness supplement without any mention of kratom on its ingredient list. FDA testing identified mitragynine and mitragynine pseudoindoxyl—alkaloids derived from the kratom plant (*Mitragyna speciosa*)—in concentrations consistent with intentional kratom extract inclusion. The regulatory agency issued an immediate consumer alert and initiated a class-wide recall, instructing retailers to remove the product from shelves and directing consumers who purchased FixElixir to discard remaining doses or return them to the point of sale.

## What the Source Says

[Newsweek reported that regulatory inspectors detected mitragynine and mitragynine pseudoindoxyl in concentrations consistent with kratom extract](https://www.newsweek.com/fda-recall-weather-fix-elixir-kratom-1906497), despite the complete absence of kratom from the product label. Mitragynine is the primary active alkaloid in kratom, acting on mu-opioid receptors in the brain to produce dose-dependent euphoria, analgesia, and sedation. Mitragynine pseudoindoxyl is a structurally related alkaloid formed during kratom processing or extended storage. The FDA's primary concern is the lack of transparency: consumers purchasing FixElixir had no mechanism to anticipate exposure to opioid-receptor-active compounds, making it impossible to assess individual risk, avoid contraindications, or monitor for adverse effects. The agency has specifically identified the potential for severe withdrawal symptoms, respiratory depression, seizures, and cardiac arrhythmias, particularly in vulnerable populations including those taking opioid medications or benzodiazepines.

## Beyond the Headline

This recall reflects a broader pattern. For years, dietary supplement manufacturers have been caught adding kratom or kratom extracts to products without labeling them, often disguising such supplements under generic wellness claims. The practice exploits regulatory gaps inherent in the Dietary Supplement Health and Education Act (DSHEA): pre-market approval is not required, and the FDA must prove a product unsafe before compelling a recall. Kratom itself occupies a legal gray zone—it is not a federally controlled substance but is banned in several U.S. states and has faced repeated FDA import alerts due to contamination and mislabeling. The presence of undeclared kratom alkaloids in FixElixir suggests either deliberate adulteration by the manufacturer or quality-control failures during ingredient sourcing. Consumers seeking natural mood support or relaxation are particularly vulnerable to such deception, as the wellness supplement market remains crowded with poorly regulated brands making vague health claims.

## What This Means for Consumers

If you have purchased or are currently using FixElixir, discontinue use immediately. Do not consume any remaining doses; instead, safely dispose of the product or return it to the retailer where it was purchased. Consumers who have been taking FixElixir and develop symptoms such as nausea, dizziness, tremor, rapid heartbeat, difficulty breathing, or confusion should seek emergency medical care and inform healthcare providers explicitly of kratom alkaloid exposure. This is especially urgent for anyone taking opioid pain medications (codeine, morphine, hydrocodone), benzodiazepines (alprazolam, diazepam), or antidepressants (SSRIs, tricyclics), as mitragynine can potentiate these drugs and increase overdose risk. Individuals with a history of liver disease, cardiac arrhythmias, or seizure disorders should be particularly cautious about undisclosed ingredients in any supplement. Beyond this specific recall, verify ingredient lists on supplement labels before purchase and check the [FDA's enforcement reports regularly](https://www.fda.gov/safety/recalls-enforcement/fda-enforcement-reports). Prioritize products carrying third-party testing seals (NSF, USP, ConsumerLab) that help ensure products contain only declared ingredients and are free of adulterants. When considering supplements for mood, stress, or sleep support, research options with published human clinical trials and consistent dosing guidance—such as [ashwagandha](/articles/ashwagandha-benefits/), which has transparent labeling standards and peer-reviewed evidence.

## What to Watch Next

The FDA is expected to release additional enforcement details including specific lot numbers, distribution channels, and the full product line of the manufacturer, helping consumers and healthcare providers identify affected batches. Retailers should monitor FDA Enforcement Reports and verify that FixElixir has been delisted from online and brick-and-mortar inventory systems. Investigators will likely conduct a root-cause analysis to determine whether kratom contamination was accidental or deliberate, potentially triggering enforcement action against the manufacturer or raw material suppliers. Expect the FDA to issue further guidance on kratom-adulterated supplements and watch for potential legislative proposals to strengthen supplement ingredient disclosure and pre-market testing requirements. Consumer advocacy organizations may petition the FDA to establish stricter labeling rules for kratom-containing products or to reclassify kratom alkaloids as controlled substances. Finally, state regulators in jurisdictions where kratom is already banned may cite this recall as justification to expand restrictions on kratom-containing dietary supplements.


## Sources
- [Supplement Recalled Over 'Fatal Physiological' Risks - Stop Taking Immediately](https://www.newsweek.com/fda-recall-weather-fix-elixir-kratom-1906497) — Newsweek

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*This article was researched and drafted with [Claude AI](https://claude.com) (Anthropic) and Google Gemini, and reviewed by an editor before publication. See our [editorial policy](https://dietarysupplement.ai/about/editorial-policy/).*

*Disclaimer: This article is for informational purposes only and is not medical advice. Always consult a qualified healthcare provider before starting, stopping, or combining supplements. These statements have not been evaluated by the FDA.*