SNI National Kratom Supplement Recall [US]

US FDA RecallUS/Silver Spring: SNI National recalls some Kratom Dietary Supplements due to an undeclared drug ingredient, a health hazard. FDA: National Kratom Supplement Recall [US]

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Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

  • Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack and Bali Kratom 40 Pack. The products are packaged in clamshell, zip sealed packets and green pill bottles with 4, 10, 20, and 40 count. The products can be identified by their bright green packaging and label stating they contain Kratom. See photo at right.

According to the FDA, Kratom is a botanical that qualifies as a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act. When marketed as a dietary ingredient, FDA considers Kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.

The recalled products were sold to wholesale distributors in Alabama, California, Illinois, Missouri, Kentucky, Florida, Oklahoma, Idaho, Colorado, Wisconsin, Massachusetts and Ohio.


Recalls Direct RIN: 3228-2014
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