Lidiy capsules recalled for undeclared sibutramine and lack of FDA approval
B @ B Trade Inc. is recalling Lidiy capsules because the dietary supplement was marketed without FDA approval and contains undeclared sibutramine.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of undeclared sibutramine in an unapproved product is a severe hazard.
Plain-English summary
B @ B Trade Inc. is recalling Lidiy capsules, a dietary supplement sold in bottles of 30 capsules. The recall involves 10 bottles distributed nationwide. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to contain undeclared sibutramine.
Sibutramine is a prescription weight-loss drug that was withdrawn from the U.S. market due to safety concerns. Its presence in an unapproved dietary supplement poses a risk of serious adverse health effects, including cardiovascular issues. The recall covers all lots of the product.
Consumers who have purchased Lidiy capsules should stop using the product immediately. They should contact the recalling firm, B @ B Trade Inc., for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
- Manufacturer
- B @ B Trade Inc.
- Category
- Drug — Dietary Supplement
- Affected units
- 10
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by B @ B Trade Inc. 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 · B @ B Trade Inc.
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FDA (Drugs) · 2014-04-23
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