CLASS I Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
Ultimate Herbal Slimcap Capsules, 350 mg* recalled
Fit Firm and Fabulous is recalling Ultimate Herbal Slimcap Capsules, 350 mg*, labeled Part 1 of 3, fit firm & fabulous, distributed nationwide in the US. The recall was initiated on 29 Sep 2015 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-0722-2016
- FDA event ID
- 72874
- Recalling firm
- Fit Firm and Fabulous, Mc Lean, VA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 Sep 2015
- FDA classified
- 18 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Labeling Errors
Timeline
| 29 Sep 2015 | Recall initiated by company | |
| 18 Feb 2016 | Classified by FDA | +142 days |
| 24 Feb 2016 | Published in enforcement report | +6 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: 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.
Product as listed by the FDA
Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.
Where it was distributed
Nationwide in the U.S.A. via the website.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 05/02/2015 to 05/01/2017
Where was it sold?
Nationwide in the U.S.A. via the website.
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.