Dream Body Weight Loss Capsules Recalled for Undeclared Sibutramine
Dream Body Weight Loss is recalling Dream Body 450 mg capsules because they contain undeclared sibutramine and were marketed without FDA approval.
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant safety concerns like undeclared active ingredients.
Plain-English summary
Dream Body Weight Loss is recalling Dream Body 450 mg 30 capsules in a plastic screw-on top bottle. 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 450 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
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