Dream Body Advanced capsules recalled for undeclared sibutramine
Dream Body Advanced 400 mg capsules are being recalled because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the presence of undeclared sibutramine (a withdrawn drug with known cardiovascular risks) constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk drug defects.
Plain-English summary
Dream Body Weight Loss is recalling Dream Body Advanced 400 mg 30 capsules in brown foil packets. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sibutramine.
The recall covers all lots of the product. The distribution pattern is listed as the United States.
Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Dream Body Advanced 400 mg 30 capsules in brown foil packets.
- 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
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FDA (Drugs) · 2016-10-26
- SevereDream Body Weight Loss Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2016-10-26
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