The Recall Desk
CriticalFDA (Drugs)·D-1277-2014·Announced 2014-05-07

Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval

Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/ANDA.

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 mandates a minimum severity score of 5 according to the rubric.

Plain-English summary

Deseo Rebajar is recalling 1,146 bottles of Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle. The product is a dietary supplement distributed nationwide and in Puerto Rico. The specific lot number is 052012, with an expiration date of 10/2015.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, FDA laboratory results detected the undeclared active pharmaceutical ingredient (API) fluoxetine in the dietary supplement.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Manufacturer
Deseo Rebajar
Category
Drug — Dietary Supplement
Hazard
Affected units
1,146

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 (2)

  • Lot #: 052012
  • Exp 10/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Deseo Rebajar

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Same hazard · undeclared api

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