The Recall Desk
CriticalFDA (Drugs)·D-1534-2014·Announced 2014-08-20

Lite Fit USA Recalled for Undeclared Sibutramine

Bacai, Inc. is voluntarily recalling Lite Fit USA supplements containing undeclared sibutramine, making them unapproved new drugs.

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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to the presence of undeclared sibutramine. The product is marketed as an extreme fat burner and appetite suppressant. The recall is being conducted because the undeclared ingredient makes the product an unapproved new drug.

The affected product consists of 14,040 softgel capsules distributed worldwide via internet sales. The specific lot number is 13165, with an expiration date of 05/17. The product is distributed by Bacai, INC. and can be found at www.litefitusa.com.

Consumers who have purchased this product should stop using it immediately. The presence of undeclared sibutramine poses a risk to consumer health as it is a controlled substance with potential for serious adverse effects, including cardiovascular issues. The FDA classifies this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
Affected units
14,040

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 #13165
  • Exp. 05/17

Distribution

Distribution scope not specified by the agency.