The Recall Desk
CriticalFDA (Drugs)·D-1222-2014·Announced 2014-04-16

Dream Body Slimming Capsule Recalled for Undeclared Sibutramine

Slim Beauty USA is recalling Dream Body Slimming Capsules because they contain undeclared sibutramine, an unapproved new drug not currently marketed in the United States.

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 severity score of 5 according to the rubric.

Plain-English summary

Slim Beauty USA is recalling Dream Body Slimming Capsules, 350 mg, 30-count bottles, made in China (Beijing). The product contains Chinese bitter orange, Cassia Seed, Aloe, Lotus Leaf Extract, and Medical Amylum. The specific lot number is 20130328, with an expiration date of 3/27/15. The recall is nationwide.

The recall is being conducted because the product contains undeclared sibutramine. Sibutramine is not currently marketed in the United States, which makes this product an unapproved new drug. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
Manufacturer
Slim Beauty USA
Affected units
3

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 # 20130328
  • Exp 3/27/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Slim Beauty USA 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 →