The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-2415-2015·Announced 2015-06-17

FDA Recalls Unlabeled Green Malay Kratom Bulk Product

The FDA is recalling 77 kg of unlabeled Green Malay Kratom bulk product in 1-gallon jugs due to the presence of Kratom.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The agency classified this as an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is the presence of Kratom in an unlabeled product, which fits the criteria for a moderate severity rating involving labeling or low-risk contamination issues without reported harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 77 kg of Green Malay/MD bulk product packaged in 1-gallon plastic jugs. The product, manufactured by Nuevotanicals, does not have a product label. The recall is being conducted because the product contains Kratom.

The affected product was 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 who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Green Malay/MD bulk in 1 gallon plastic jugs, no product label
Manufacturer
Nuevotanicals

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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