Jenesis Dietary Supplement Capsules Recalled for Unapproved Ingredients
Bee Xtreme is recalling Jenesis Dietary Supplement Capsules because FDA analysis found unapproved ingredients sibutramine and phenolphthalein.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Bee Xtreme is recalling 13 bottles of Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles. The product was manufactured for Timeless Solutions and distributed by BeeXtreme LLC. The recall covers all lots of the product.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the capsules contain sibutramine and phenolphthalein, which are unapproved ingredients in this context.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
- Manufacturer
- Bee Xtreme
- Category
- Drug — Dietary Supplement
- Affected units
- 13
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 Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Bee Xtreme under a single FDA (Drugs) 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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