CLASS I Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
350 mg recalled by Super Herbs
Super Herbs is recalling Super Herbs 350 mg per. The recall was initiated on 23 Nov 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-0909-2016
- FDA event ID
- 73361
- Recalling firm
- Super Herbs, Miami, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 23 Nov 2015
- FDA classified
- 26 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 23 Nov 2015 | Recall initiated by company | |
| 26 May 2016 | Classified by FDA | +185 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 - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Product as listed by the FDA
SUPER HERBS 350 mg, 30 capsules per bottle.
Where it was distributed
9 consignees - only 9 bottles distributed
Questions about this recall
Is 350 mg per recalled?
Yes. Super Herbs recalled 350 mg per on 23 Nov 2015. The recall is Class I and its status is Terminated. Recall number D-0909-2016.
Why was it recalled?
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Which lots are affected?
All lots
Where was it sold?
9 consignees - only 9 bottles distributed
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 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.