Dream Body Extreme Gold Recalled for Undeclared Sibutramine
Dream Body Weight Loss is recalling Dream Body Extreme Gold capsules because they contain undeclared sibutramine and were marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a withdrawn, high-risk undeclared drug.
Plain-English summary
Dream Body Weight Loss is recalling Dream Body Extreme Gold 800 mg capsules, sold in 30-count plastic bottles. The recall covers all lots of the product distributed in the United States.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sibutramine. Sibutramine is a weight-loss drug that was withdrawn from the US market due to safety concerns.
Consumers who have purchased Dream Body Extreme Gold should stop using the product immediately. They should contact Dream Body Weight Loss for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
- Manufacturer
- Dream Body Weight Loss
- Category
- Drug — Weight Loss Supplement
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 Dream Body Weight Loss 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 →Related recalls
Same manufacturer · Dream Body Weight Loss
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FDA (Drugs) · 2016-10-26
- SevereDream Body Advanced capsules recalled for undeclared sibutramine
FDA (Drugs) · 2016-10-26
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