# FDA recall D-0722-2016

> **Fit Firm and Fabulous** · Class I · drug recall initiated 2015-09-29.

## Product

Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.

## Reason for recall

Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.

## Distribution

Nationwide in the U.S.A. via the website.

## Key facts

- **Recall number:** D-0722-2016
- **Recalling firm:** Fit Firm and Fabulous
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-29
- **Report date:** 2016-02-24
- **Termination date:** 2016-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mc Lean, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0722-2016

## Citation

> AI Analytics. FDA recall D-0722-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0722-2016. Source: US FDA. Licensed CC0.

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