# FDA recall D-0860-2016

> **Lipo Escultura Corp.** · Class I · drug recall initiated 2015-12-03.

## Product

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com

## Reason for recall

Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.

## Distribution

Nationwide via Internet sales

## Key facts

- **Recall number:** D-0860-2016
- **Recalling firm:** Lipo Escultura Corp.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-03
- **Report date:** 2016-06-01
- **Termination date:** 2017-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0860-2016

## Citation

> AI Analytics. FDA recall D-0860-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0860-2016. Source: US FDA. Licensed CC0.

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