FDA Alerts — Kratom (Mitragynine)
This page lists FDA-published alerts —including warning letters, consumer updates, enforcement actions, and recalls related to kratom (mitragynine) and 7-hydroxymitragynine. No FAERS or CAERS summaries are included here.
FDA Alerts & Warning Letters — Kratom / 7-OH
The FDA issued a warning to 7Tabz Retail, LLC for marketing and distributing products containing 7-hydroxymitragynine (7-OH)—a potent kratom alkaloid—alongside pseudoephedrine blends. These products were sold as unapproved new drugs making pain, mood, and focus claims. FDA emphasized the opioid-like pharmacology of 7-OH, reports of adverse events, and the company’s child-appealing packaging. The supplements were deemed adulterated under the Federal Food, Drug, and Cosmetic Act. View FDA Warning Letter (PDF)
FDA laboratory analysis found Salmonella contamination in multiple raw kratom samples at Avalon Packaging’s Utah facility, several of which were genetically linked to a multistate outbreak. The inspection also revealed severe Good Manufacturing Practice (GMP) violations, including missing batch records and no established safety specifications. FDA determined the company’s kratom products to be adulterated and unsafe as new dietary ingredients. View FDA Warning Letter (PDF)
Badger Botanicals voluntarily recalled several kratom products, including Red Suma, Green Suma, Green Hulu 2, and Red Hulu 2 sold under the Acadica brand, because of potential Salmonella contamination. The products were distributed online from January to April 2018, and one possible illness was reported. FDA testing confirmed contamination, prompting a nationwide consumer warning. View FDA Recall Notice (PDF)
Blissful Remedies recalled Red Maeng Da, Ultra Enhanced Indo, and Kratom + CBD Capsules after FDA testing identified Salmonella contamination. The products were sold nationwide in 50-count white foil pouches (lot 112710, exp 03/2019). Although no illnesses were reported, FDA warned consumers to stop use immediately and discard any affected product. View FDA Recall Notice (PDF)
The FDA warned Cali Botanicals LLC for selling kratom powders, capsules, and tinctures marketed as treatments for opioid withdrawal, pain, anxiety, depression, and diabetes. The agency determined these products to be unapproved, misbranded drugs and noted claims that kratom “acts as a μ-opioid receptor like morphine.” FDA stated such claims may lead consumers to delay proven medical treatment for addiction. View FDA Warning Letter (PDF)
FDA cited ChillinMixKratom.com for marketing kratom powders and capsules as treatments for a wide array of conditions including opiate withdrawal, addiction, anxiety, obesity, and alcoholism. All items were declared unapproved and misbranded drugs. FDA emphasized that such promotion of kratom as an opioid-withdrawal aid during the national opioid crisis presents serious public-health risks. View FDA Warning Letter (PDF)
Club 13 recalled its Maeng Da Red Kratom powders and capsules (lot MRMD012618 and related lots) due to Salmonella contamination identified by the Oklahoma Department of Agriculture. No illnesses were reported, but the products had been distributed nationwide. The FDA advised all consumers to discard any remaining products. View FDA Recall Notice (PDF)
The FDA publicly objected to Industrial Chemicals LLC for marketing a high-purity kratom extract, branded “Mitrasafe,” as a natural substitute for prescription opioids. The agency warned that the product was being promoted with unproven claims to treat addiction and withdrawal and lacked safety data for human use. FDA testing indicated toxic effects at all examined doses, leading to classification of Mitrasafe as an unapproved new drug and adulterated dietary supplement. View FDA Brief (PDF)
The FDA, in coordination with the CDC, launched an investigation after 28 confirmed cases of Salmonella infection were reported in 20 states, all linked to kratom-containing products consumed as pills, powders, or teas. Eleven hospitalizations occurred. The FDA warned consumers to avoid all kratom products and initiated product testing, which led to a series of recalls across multiple companies, including PDX Aromatics and Triangle Pharmanaturals. View FDA Investigation Notice (PDF)
The FDA issued its first-ever mandatory recall order under the Food Safety Modernization Act after detecting Salmonella in multiple kratom products produced by Triangle Pharmanaturals LLC. The company refused to conduct a voluntary recall, triggering the mandatory enforcement action. The order covered several kratom brands including Raw Form Organics, Molecule, Naturally, Lifted, Live Well, and Third Eye. View FDA Mandatory Recall Order (PDF)
The FDA announced a formal recommendation to classify 7-hydroxymitragynine (7-OH) as a controlled substance, describing it as a potent opioid more powerful than morphine. The agency highlighted that 7-OH is not lawful in foods or supplements and raised specific concern over child-appealing formulations such as gummies, candies, and ice cream cones. The press release emphasized public-health risks and indicated that DEA scheduling action would follow. View FDA Press Release (PDF)
The FDA issued an urgent alert warning consumers to avoid OPMS Black Liquid Kratom after receiving multiple reports of serious adverse effects, including addiction, seizures, anxiety, liver toxicity, and one death. The agency reiterated that no kratom-containing products are FDA-approved and emphasized that mitragynine and 7-hydroxymitragynine can cause dependence and withdrawal. View FDA Consumer Warning (PDF)
FDA testing identified bacterial contamination—including Klebsiella pneumoniae and Enterobacter species— in products sold by Kratom NC. The company refused to voluntarily recall the affected items. The FDA concurrently issued a warning letter citing illegal opioid-treatment claims and product misbranding. Consumers were urged to avoid all kratom products from the firm. View FDA Alert (PDF)
In this policy overview, the FDA reaffirmed that kratom and its alkaloids are not lawfully marketed in the U.S. as drugs, foods, or dietary supplements. The agency summarized research showing risks of addiction, liver injury, seizures, neonatal withdrawal, and contamination with heavy metals and Salmonella. FDA also discussed funding new studies on kratom’s abuse potential and toxicity, stressing that kratom cannot legally be added to food or sold as a supplement. View FDA Overview (PDF)
Gaia Ethnobotanical voluntarily recalled all of its kratom powders (lot 0102031800) after FDA testing confirmed Salmonella contamination. The products—distributed to over 40 states—included numerous strains such as Red Bali, Green Malay, and White Horn packaged in 1-oz to 1-kg bags. No fatalities were reported, but the company cooperated fully with the FDA in removing all affected lots. View FDA Recall Notice (PDF)
The FDA and FTC jointly warned Herbsens Botanicals for promoting kratom as a treatment for pain, depression, PTSD, and opioid withdrawal, calling it a “morphine-like” herbal remedy. The agencies found the claims deceptive and unsubstantiated, ordering the firm to cease unlawful advertising. FDA classified the products as unapproved and misbranded drugs sold across state lines. View FDA/FTC Warning Letter (PDF)
The FDA issued a warning to Hydroxie, LLC for marketing 7-hydroxymitragynine (7-OH) products—including tablets, sublingual strips, and powdered drink mixes—as unapproved new drugs. The firm made claims related to pain relief, anxiety, depression, and fibromyalgia while promoting the products online and on social media as enhancing “focus and clarity.” The FDA determined the drink mixes to be adulterated foods since 7-OH is not an approved or safe additive and noted the heightened risk to consumers due to the compound’s opioid-like activity. View FDA Warning Letter (PDF)
FDA investigators found that Tianaa Red, White, and Green kratom products distributed by Jack B Goods Outlet Store were being sold as treatments for pain, anxiety, and opioid withdrawal. The products contained tianeptine, which the FDA classifies as an unsafe food additive and an unapproved drug ingredient. The agency warned the company for marketing misbranded and adulterated drugs that could pose severe health risks, especially due to tianeptine’s potential for dependence and withdrawal. View FDA Warning Letter (PDF)
The FDA and FTC jointly cited Klarity Kratom for promoting its kratom capsules and powders as effective for pain, arthritis, and opioid withdrawal. The agency highlighted misleading testimonials such as “It’s been great to give up the opioids and feel good.” These claims violated the Opioid Addiction Recovery Fraud Prevention Act, exposing the firm to potential civil penalties of up to $46,517 per violation. The products were classified as unapproved and misbranded drugs. View FDA/FTC Warning Letter (PDF)
The FDA and FTC warned Kratom Exchange for marketing kratom as an effective treatment for opioid withdrawal, depression, PTSD, diabetes, and hypertension. Claims such as “Kratom can treat opioid addiction without adverse effects” and “It regulates blood pressure” were deemed false and misleading. The agencies determined the products were unapproved drugs and that the firm engaged in deceptive health marketing under federal advertising law. View FDA/FTC Warning Letter (PDF)
FDA cited Kratom Spot for marketing its kratom powders and capsules as a “natural alternative” to opioids with claims such as “Kratom can successfully eliminate opiate withdrawal symptoms.” The agency determined that the company’s claims promoted unapproved and misbranded drugs and risked misleading consumers away from legitimate medical care during the opioid crisis. View FDA Warning Letter (PDF)
Kula Brands LLC recalled its Kula Can Pina Colada + Kratom Seltzer after discovering undeclared coconut and milk allergens. The 12-oz cans (UPC 371334085880, Lot U17831532PNCL) were distributed nationwide via retail and mail order. No illnesses were reported, but consumers with tree-nut or milk allergies were advised to return or discard the product immediately. View FDA Allergy Alert (PDF)
The FDA analyzed 30 kratom products and discovered widespread contamination with lead and nickel, often exceeding safe daily intake limits. Chronic consumption of contaminated kratom could lead to neurological damage, anemia, kidney impairment, and cancer risk. Among the worst findings were: • Kratom Spot Red Vein Sumatra: 22,600–29,000 ng/g nickel and 777 ng/g lead. • Krave Botanicals Gold: 10,000 ng/g nickel. • Mood & Mind Private Reserve Maeng Da: 9,020 ng/g nickel. View FDA Laboratory Report (PDF)
Maya Distribution, LLC recalled its Dragon Kratom line of capsules and powders after FDA testing confirmed Salmonella contamination. Distributed across nine states, the recall followed one confirmed illness. The affected products included Dragon Maeng Da, Malaysian, and Bali Kratom, packaged in 40- to 200-count bottles. View FDA Recall Notice (PDF)
FDA warned Mitra Distributing Inc. for selling kratom powders promoted to treat opioid withdrawal, depression, obesity, high blood pressure, and anxiety. The company’s products were marketed as a “natural alternative” for heroin addiction and deemed unapproved and misbranded drugs posing public-health risks. View FDA Warning Letter (PDF)
NGB Corp. recalled its NxtGen Botanicals Maeng Da Kratom (lot 171409) after FDA testing detected Salmonella contamination. About 1,100 units were sold through 27 retailers in six states, and one illness was reported. All contaminated bottles were destroyed under FDA supervision, and the agency advised consumers to avoid any remaining product. View FDA Recall Notice (PDF)
NutriZone LLC expanded its voluntary recall to include all kratom supplements sold under the Pain Out, Nirvanio, and Cali brands due to potential Salmonella contamination. The affected products were distributed nationwide across at least 15 states. Although no illnesses were reported, FDA sampling confirmed contamination in multiple lots during routine testing. View FDA Expanded Recall (PDF)
The FDA and FTC jointly warned YoKratom.com for advertising kratom strains—such as Red Maeng Da, Red Bali, and White Borneo— as treatments for opioid addiction and pain relief. Promotional claims like “great for heroin and opiate withdrawal” were deemed deceptive. The agencies cited the company under the Opioid Addiction Recovery Fraud Prevention Act, exposing it to potential penalties of up to $46,517 per violation for false health claims. The products were classified as unapproved and misbranded drugs. View FDA/FTC Warning Letter (PDF)
PDX Aromatics, which operates as Kraken Kratom, Phytoextractum, and Soul Speciosa, issued multiple nationwide recalls after FDA and CDC testing confirmed Salmonella contamination in various kratom powders and capsules. The recalls were later expanded to cover additional products and lot numbers distributed domestically and internationally. Four illnesses were confirmed during the FDA investigation. The recalls demonstrated early national awareness of contaminated kratom supply chains. View Initial Recall (PDF)
View Expanded Recall (PDF)
View Second Expanded Recall (PDF)
Pious Lion voluntarily recalled its Pink Bali and White Maeng Da kratom products after FDA testing confirmed Salmonella contamination. The products were distributed in North Carolina and Tennessee between January and April 2018. No illnesses were reported, but consumers were urged to stop using affected products and sanitize any surfaces exposed to them. View FDA Recall Notice (PDF)
FDA laboratory analysis identified tadalafil (a prescription drug) and kratom alkaloids mitragynine and paynantheine in a product marketed as “Detox Plus.” The product was sold for digestive health and detox purposes but contained undeclared active drugs. The FDA warned that its use could cause dangerous blood-pressure drops, dependence, and drug interactions. Consumers were urged to discontinue use immediately. View FDA Public Notification (PDF)
The FDA warned RRR Trading / EDP Kratom for selling EDP 7OH Mitragyna Speciosa Extract Shots labeled as containing 7-hydroxymitragynine (7-OH). These products were classified as adulterated dietary supplements under the FD&C Act due to the lack of safety data and known opioid-like dependence potential of 7-OH. The agency also cited misleading marketing that implied pain-relief and mood benefits without FDA approval. View FDA Warning Letter (PDF)
FDA found that BuyKratomBulkUSA.com, operated by Revibe, Inc., was marketing multiple kratom strains with claims to cure pain, arthritis, depression, cancer, stroke, and opioid withdrawal. Statements such as “It cures chronic pain” and “Kratom can eliminate drug dependency completely” were deemed illegal medical claims. The FDA concluded the products were unapproved and misbranded drugs posing serious risks to consumers. View FDA Warning Letter (PDF)
The FDA cited Royal Diamond Imports for distributing Roxy Instamix and ROXY 7-OH Tablets marketed for pain relief, relaxation, and mood enhancement. The agency determined the products to be unapproved new drugs and adulterated food items under the FD&C Act, noting their child-appealing packaging and opioid-like pharmacology of 7-hydroxymitragynine. View FDA Warning Letter (PDF)
The FDA warned Shot of Joy LLC for marketing kratom and kava products (shots and gummies) as treatments for opioid addiction, depression, and anxiety. The products were sold as dietary supplements but made unapproved drug claims. The FDA stated such products pose public-health risks by discouraging patients from seeking approved medical therapies for addiction. View FDA Warning Letter (PDF)
FDA warned Nova Kratom for marketing kratom powders with claims that they relieve pain, anxiety, and opioid withdrawal. The company’s website described mitragynine and 7-hydroxymitragynine as “acting on opioid receptors.” FDA declared these products to be unapproved new drugs sold in violation of federal law. View FDA Warning Letter (PDF)
Sunstone Organics recalled its White Vein Kratom and Maeng Da Kratom (lots 119 and 124A) due to potential Salmonella contamination. The products were distributed in four states in capsule and powder form. FDA advised consumers to stop use and sanitize all surfaces exposed to the products. View FDA Recall Notice (PDF)
Tamarack Inc. recalled Eclipse Kratom Maeng Da capsules and powders after FDA testing confirmed Salmonella contamination. Approximately 120 units were distributed to five Utah retailers. While no illnesses were reported, FDA urged immediate product disposal to prevent infection. View FDA Recall Notice (PDF)
FDA cited Thang Botanicals, Inc. for selling 7-hydroxymitragynine (7-OH) gummies, drinks, and kratom shots marketed as dietary supplements and foods. The agency determined that 7-OH and kratom extracts are unsafe food additives and not “generally recognized as safe.” FDA highlighted risks of addiction, seizures, liver and cardiac toxicity, and respiratory depression, particularly due to child-appealing packaging and online promotion. View FDA Warning Letter (PDF)
The FDA issued a warning to The Golden Road Kratom for making fraudulent COVID-19 prevention and treatment claims. The company falsely asserted that kratom contained “chloroquine” and could “keep the coronavirus at bay.” These statements were found to be misleading and illegal under the Federal Food, Drug, and Cosmetic Act. The FDA demanded immediate removal of all COVID-related claims and classified the products as unapproved and misbranded drugs. View FDA Warning Letter (PDF)
The FDA announced a mandatory recall of Triangle Pharmanaturals kratom products after multiple samples tested positive for Salmonella contamination. The firm refused to cooperate with a voluntary recall, leading the FDA to exercise its first-ever mandatory recall authority under the Food Safety Modernization Act. Affected brands included Raw Form Organics, Molecule, Chameleon, Naturally, Lifted, Live Well, and Third Eye. View FDA Recall Notice (PDF)
At the FDA’s request, U.S. Marshals seized nearly 90,000 bottles of kratom dietary supplements valued at $400,000 from Dordoniz Natural Products in Illinois. The FDA classified the products as unsafe, adulterated, and misbranded, citing kratom’s opioid-like effects and risks of respiratory depression, vomiting, and addiction. This marked one of the first major enforcement actions against commercial kratom distribution in the United States. View FDA Enforcement Report (PDF)
The FDA cited Umbrella for selling a broad range of unapproved and misbranded products, including kratom powders marketed for opioid withdrawal, tianeptine and SARMs for bodybuilding, and NACET powder advertised as a COVID-19 preventative. The agency found multiple violations across several company websites, emphasizing the public-health risks of unregulated drug claims. View FDA Warning Letter (PDF)
The FDA announced a recall of Monarch Premium Kratom powders—including Bali Gold, Red Bali, Green Maeng Da, and White Elephant— after testing by the Florida Department of Agriculture confirmed Salmonella contamination. The affected products, packaged in mylar pouches (lots 020123PA3F-T/G/R/W), were distributed nationwide via retail and online sales. Consumers were advised to stop use immediately and discard affected lots. View FDA Recall Notice (PDF)
The FDA’s Center for Tobacco Products cited Vape Hut LLC for marketing unauthorized nicotine products under the “Kratom–CBD” label. The firm distributed new tobacco products without premarket authorization, rendering them adulterated and misbranded. The letter warned of potential civil penalties, product seizures, and injunctions for continued violations. View FDA Warning Letter (PDF)
Viable Solutions LLC, doing business as Herbal-Salvation, recalled Red Vein Sumatra, Red Bali, Green Horn, and Thai Maeng Da kratom powders after FDA and Michigan health officials found Salmonella contamination. The affected products, distributed nationwide in 25 g to 1 kg bags, were voluntarily withdrawn, and all contaminated lots were destroyed under FDA oversight. View FDA Recall Notice (PDF)
World Organix LLC issued a nationwide recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules due to Salmonella contamination. The affected products were packaged in 50-count foil pouches labeled “All Natural – Chemical Free.” This recall mirrored the Blissful Remedies contamination event earlier that year. FDA later marked the recall as completed. View FDA Recall Archive (Web File)
Zakah Life LLC recalled Super Green Maeng Da and Red Vein Bali Kratom powder and capsule products after FDA testing confirmed Salmonella contamination. The products were sold nationwide in 100-gram bags and 90-count bottles. No illnesses were reported, but production was suspended pending investigation. View FDA Recall Notice (PDF)
These FDA actions concern kratom and 7-OH in drug or food/dietary products (e.g., “shots,” gummies, powders, capsules).
They focus on unapproved drug claims, adulteration (e.g., 7-OH in foods/supplements, Salmonella contamination),
and misbranding, as well as first-of-its-kind mandatory recalls.