CLASS I Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report
Prime Capsules, 500mg recalled by Bee Extremely Amazed
Bee Extremely Amazed is recalling Prime Capsules, 500mg, distributed nationwide in the US. The recall was initiated on 15 Dec 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-1145-2016
- FDA event ID
- 71187
- Recalling firm
- Bee Extremely Amazed, Jewett, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Dec 2015
- FDA classified
- 6 Jul 2016
- Reported
- 13 Jul 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
| 15 Dec 2015 | Recall initiated by company | |
| 6 Jul 2016 | Classified by FDA | +204 days |
| 13 Jul 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: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Product as listed by the FDA
Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
Where it was distributed
Nationwide
Questions about this recall
Is Prime Capsules, 500mg recalled?
Yes. Bee Extremely Amazed recalled Prime Capsules, 500mg on 15 Dec 2015. The recall is Class I and its status is Terminated. Recall number D-1145-2016.
Why was it recalled?
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
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 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 Bee Extremely Amazed
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | ZI Xiu Tang Beauty Face & Figure Capsules, 250 mg recalled | Bee Extremely Amazed | Labeling Errors | Nationwide |
| Drug | CLASS I | Asset extreme+PLUS Capsules, 500 mg recalled by Bee Extremely Amazed | Bee Extremely Amazed | Labeling Errors | Nationwide |
| Drug | CLASS I | XCEL Capsules, 300 mg recalled by Bee Extremely Amazed | Bee Extremely Amazed | Labeling Errors | Nationwide |
| Drug | CLASS I | Evolve Bee Pollen Capsules, 250mg recalled by Bee Extremely Amazed | Bee Extremely Amazed | Labeling Errors | Nationwide |
| Drug | CLASS I | Xcel Advanced Capsules, 350mg recalled by Bee Extremely Amazed | Bee Extremely Amazed | Labeling Errors | Nationwide |