The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-1021-2018·Announced 2018-04-25

Kratom Powder Recalled Due to Inadequate Safety Information for New Ingredient

Divinity Product Distribution LLC is recalling kratom powder products because the ingredient lacks sufficient safety data to ensure it does not pose a risk of illness or injury.

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 classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the lack of safety assurance for a new dietary ingredient.

Plain-English summary

Divinity Product Distribution LLC is recalling specific kratom powder products labeled as Enhance Your Life, Bali Kratom, and Botany Bay. The recall involves various package sizes, including 150 grams, 15 grams, 30 grams, 60 grams, 120 grams, and 1 ounce.

The FDA has determined that kratom (Mitragyna speciosa) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. The agency has classified this recall as Class II.

The affected products were distributed to numerous U.S. states and countries, including Alaska, Alabama, Arizona, California, Canada, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, United Kingdom, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. Consumers should check their lot codes; the recall includes all lot codes with expiration dates after January 31, 2018. Consumers should stop using these products and contact the firm for instructions on disposal or return.

The recalled product

Product
Kratom powder labeled in the following ways 1) Enhance Your Life, Kratom Essence Maeng Da Mitragyna speciosa, 150 gras; 2) Bali Kratom, 15 g Powdered; 3) Bali Kratom, 30 g Powdered; 4) Bali Kratom, 60 g Powdered; 5) Bali Kratom, 120 g Powdered; 6) Botany Bay, 1 oz
Manufacturer
Divinity Product Distribution LLC
Category
Food — Dietary Supplement
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 lot codes with expiration dates after 1/31/2018

Distribution

Distributed in 44 states:

Part of a larger recall action

This product is one of 2 recalled by Divinity Product Distribution LLC 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 2 products in this recall →

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