CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento recalled
Herbal Give Care is recalling Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, Hecho En Mexico, distributed nationwide in the US. The recall was initiated on 19 Jul 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1329-2014
- FDA event ID
- 65774
- Recalling firm
- Herbal Give Care, Grand Prairie, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Jul 2013
- FDA classified
- 20 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 19 Jul 2013 | Recall initiated by company | |
| 20 May 2014 | Classified by FDA | +305 days |
| 28 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Product as listed by the FDA
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060
Where it was distributed
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Which lots are affected?
All lots
Where was it sold?
Products were sold to distributors nationwide. Recalling firm sold some product directly to consumers.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 65774This product is part of a recall event; the main page for the event is Esbelder Siloutte Suplemento Alimenticio recalled by Herbal Give Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Esbelder Siloutte Suplemento Alimenticio recalled by Herbal Give Care | Herbal Give Care | Labeling Errors | Nationwide | |
| CLASS I | Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea recalled | Herbal Give Care | Labeling Errors | Nationwide | |
| CLASS I | Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio recalled | Herbal Give Care | Labeling Errors | Nationwide | |
| CLASS I | Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement recalled | Herbal Give Care | Labeling Errors | Nationwide |
More recalls from Herbal Give Care
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement recalled | Herbal Give Care | Labeling Errors | Nationwide |
| Drug | CLASS I | Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio recalled | Herbal Give Care | Labeling Errors | Nationwide |
| Drug | CLASS I | Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea recalled | Herbal Give Care | Labeling Errors | Nationwide |
| Drug | CLASS I | Esbelder Siloutte Suplemento Alimenticio recalled by Herbal Give Care | Herbal Give Care | Labeling Errors | Nationwide |