The Recall Desk
Agency classClass IIOur severity:HighFDA (Food)·F-2414-2015·Announced 2015-06-17

FDA Recalls Kr8om Max Kratom Tablets Due to Kratom Content

Nuevotanicals is recalling Kr8om Max2, Max5, and Max10 tablets because they contain Kratom. The products were distributed in 12 states.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report specific illnesses or injuries, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nuevotanicals, LLC is voluntarily recalling Kr8om Max2, Kr8om Max5, and Kr8om Max10 tablets. The recall is being conducted because the products contain Kratom. The tablets are packed in round, clear plastic containers with screw-on lids and are labeled as "All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112."

The affected products include 2,066 units manufactured since June 1, 2011. The recall covers distribution in Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia. The FDA has classified this recall as Class II.

Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions. The specific reason for the recall beyond the presence of Kratom is not detailed in the provided source text.

The recalled product

Product
Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 5 tablets; Kr8om Max10 All-Natural Extraction…
Manufacturer
Nuevotanicals
Category
Food — Dietary Supplement
Hazard
Affected units
2,066

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All products manfactured since 6/1/2011

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 10 recalled by Nuevotanicals under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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