CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
Smart Lipo Dietary Supplement capsules, 900 mg recalled
Centro Naturista is recalling Smart Lipo Dietary Supplement capsules, 900 mg, distributed nationwide in the US. The recall was initiated on 3 Jun 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-0878-2016
- FDA event ID
- 71401
- Recalling firm
- Centro Naturista, Dallas, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Jun 2015
- FDA classified
- 26 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 3 Jun 2015 | Recall initiated by company | |
| 26 May 2016 | Classified by FDA | +358 days |
| 1 Jun 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 contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Product as listed by the FDA
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Which lots are affected?
All lots
Where was it sold?
Nationwide
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
1 other product · FDA event 71401| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Smart Lipo Dietary Supplement capsules, 800 mg recalled | Centro Naturista | Labeling Errors | Nationwide |
More recalls from Centro Naturista
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Smart Lipo Dietary Supplement capsules, 800 mg recalled | Centro Naturista | Labeling Errors | Nationwide |
| Food | CLASS II | Smart Lipo Dietary Supplement capsules, 950 mg recalledSmart Lipo | Centro Naturista | Foreign Material | Nationwide |
Other Smart Lipo Dietary Supplement recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Smart Lipo Dietary Supplement capsules, 800 mg recalled | Centro Naturista | Labeling Errors | Nationwide |