CLASS II Drug recall · Reported 26 Oct 2016 · FDA Enforcement Report
Dream Body Extreme Gold 800 mg recalled
Dream Body Weight Loss is recalling Dream Body Extreme Gold 800 mg in a. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class II.
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-0106-2017
- FDA event ID
- 74588
- Recalling firm
- Dream Body Weight Loss, Grand Prairie, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2016
- FDA classified
- 19 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 1 Jul 2016 | Recall initiated by company | |
| 19 Oct 2016 | Classified by FDA | +110 days |
| 26 Oct 2016 | Published in enforcement report | +7 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: Undeclared sibutramine.
Product as listed by the FDA
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Where it was distributed
United States
Questions about this recall
Is Dream Body Extreme Gold 800 mg in a recalled?
Yes. Dream Body Weight Loss recalled Dream Body Extreme Gold 800 mg in a on 1 Jul 2016. The recall is Class II and its status is Terminated. Recall number D-0106-2017.
Why was it recalled?
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Which lots are affected?
All lots.
Where was it sold?
United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dream Body Weight Loss
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dream Body 450 mg recalled | Dream Body Weight Loss | Labeling Errors | TX |
| Drug | CLASS II | Dream Body Advanced 400 mg in brown foil packets recalled | Dream Body Weight Loss | Labeling Errors | TX |