The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-2413-2015·Announced 2015-06-17

FDA Recalls Kr8om Max Kratom Capsules Due to Kratom Content

Nuevotanicals is recalling Kr8om Max3 and Kr8om Max10 capsules 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when specific hazard criteria like hospitalization are not explicitly detailed but the classification itself mandates a higher risk level than moderate.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Kr8om Max3 and Kr8om Max10 capsules manufactured by NUEVOtanicals, LLC. The recall is being conducted because the products contain Kratom. The agency has classified this recall as Class II.

The affected products are 3-capsule and 10-capsule containers packed in round, clear plastic screw-on lid containers. The dosage instructions state "1 capsule after a meal," with each capsule containing "4.4 g leaf equiv." A total of 1,372 units are involved in this recall.

The products were distributed in Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia. The recall covers all products manufactured since June 1, 2011. Consumers should stop using these products and follow instructions from the recalling firm or the FDA regarding disposal or return.

The recalled product

Product
Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round…
Manufacturer
Nuevotanicals
Category
Food — Dietary Supplement
Hazard
Affected units
1,372

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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