Herbal Give Care Recalls Esbelder Siloutte Supplement for Undeclared Sibutramine
Herbal Give Care is recalling Esbelder Siloutte dietary supplements because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
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 meets the rubric criteria for a Critical severity score.
Plain-English summary
Herbal Give Care Llc is recalling 54 bottles of Esbelder Siloutte Suplemento Alimenticio, a 30-capsule dietary supplement. The recall was initiated because the products were found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. Sibutramine was previously removed from the U.S. market for safety reasons, which makes these products unapproved new drugs.
The recalled products were sold to distributors nationwide, and the recalling firm also sold some product directly to consumers. All lots of the product are affected. The product is identified by the UPC 7502011000268.
Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268
- Manufacturer
- Herbal Give Care Llc
- Category
- Drug — Dietary 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Herbal Give Care Llc 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 5 products in this recall →Related recalls
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