Divinity Kratom Capsules Recalled Due to Unapproved New Dietary Ingredient
Divinity Product Distribution LLC is recalling kratom capsules because the ingredient lacks adequate safety information to ensure it does not present a significant risk of illness or injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the hazard involves a significant or unreasonable risk of illness or injury due to an unapproved new dietary ingredient.
Plain-English summary
Divinity Product Distribution LLC is recalling specific lots of kratom capsules. The affected products include Divinity Kratom 10 Capsule Dietary Supplement, Divinity Bali Kratom 10PK Capsules, Divinity Bali Kratom 20PK Capsules, and Divinity Bali Kratom 40PK Capsules. The recall applies to all lot codes with expiration dates after January 31, 2018.
The FDA issued this recall because the products contain kratom (Mitragyna speciosa), which is classified as a new dietary ingredient. The agency determined that there is inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness or injury.
The products were distributed to numerous U.S. states, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV, as well as to Austria, Canada, and the United Kingdom. Consumers should stop using these products and contact the recalling firm for instructions on how to return them or obtain a refund.
The recalled product
- Product
- Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules;
- Manufacturer
- Divinity Product Distribution LLC
- Category
- Food — Dietary Supplement
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
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.
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