The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-2410-2015·Announced 2015-06-17

Nuevotanicals Recalls Kratom Alkaloid Suspension Oil Products

Nuevotanicals is recalling Kratom alkaloid suspension oil products because they contain 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 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 FDA has classified this recall as Class II, which corresponds to a Severe severity score under the rubric.

Plain-English summary

Nuevotanicals is recalling Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg, 200 mg, and 300 mg dosages, and Kratom (KR8om) Bali Custom Alkaloid Suspension Oil in 175 mg dosage. The recall involves 52,552 units and 9 kg in bulk. The products were distributed in Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia.

The recall is being conducted because the products contain Kratom. All products manufactured since June 1, 2011, are affected. The FDA has classified this recall as Class II.

Consumers who have purchased these products should stop using them and contact Nuevotanicals for further instructions.

The recalled product

Product
Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg., 200 mg., and 300 mg. dosages and Kratom (KR8om) Bali Custom Alkaloid Suspension Oil in 175 mg dosage
Manufacturer
Nuevotanicals
Hazard

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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