BotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine
BotanicalNow is recalling BodySlim Herbal capsules because FDA analysis found undeclared sibutramine, a substance not approved for use in this product.
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 recall is classified as 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 The presence of undeclared sibutramine, a withdrawn prescription drug, in an unapproved supplement meets the criteria for a Critical severity rating.
Plain-English summary
BotanicalNow is recalling 5 bottles of BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle. The product is identified by the barcode 9567153432481 and has a manufacture date of 05.06.2016 and an expiration date of 05.05.2018. The recall covers distribution across the U.S.A. Nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains undeclared sibutramine. Sibutramine is a prescription drug that was withdrawn from the U.S. market due to safety concerns, and its presence in an unapproved herbal supplement poses a significant health risk.
Consumers who have purchased this product should stop using it immediately. They should contact BotanicalNow for further instructions on how to return the product or obtain a refund. The presence of undeclared pharmaceutical ingredients in dietary supplements can lead to serious adverse health effects, particularly in individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
- Manufacturer
- BotanicalNow
- Category
- Drug — Dietary Supplement
- Affected units
- 5
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)
- MFD: 05.06.2016 EXP: 05.05.2018
Distribution
Distributed nationwide across the United States.
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