The Recall Desk
CriticalFDA (Drugs)·D-0021-2017·Announced 2016-10-19

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
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.

See all 3 products in this recall →

Same manufacturer · Bee Xtreme

See all →