CLASS I Drug recall · Reported 23 Apr 2014 · FDA Enforcement Report
PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule recalled
Haute Health is recalling PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, distributed nationwide in the US. The recall was initiated on 27 Sep 2013 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-1236-2014
- FDA event ID
- 66406
- Recalling firm
- Haute Health, Williamstown, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Sep 2013
- FDA classified
- 15 Apr 2014
- Reported
- 23 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 27 Sep 2013 | Recall initiated by company | |
| 15 Apr 2014 | Classified by FDA | +200 days |
| 23 Apr 2014 | Published in enforcement report | +8 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: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
Where it was distributed
Nationwide and internationally via internet sales.
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Which lots are affected?
All lot codes and expiration dates.
Where was it sold?
Nationwide and internationally via internet sales.
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
2 other products · FDA event 66406This product is part of a recall event; the main page for the event is Prolifta Dietary Supplement Prolifta, 400mg/capsule recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Prolifta Dietary Supplement Prolifta, 400mg/capsule recalled | Haute Health | Hidden Drug Ingredients | Nationwide | |
| CLASS I | Virilis Pro, 450mg/capsule recalled by Haute Health | Haute Health | Hidden Drug Ingredients | Nationwide |
More recalls from Haute Health
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Virilis Pro, 450mg/capsule recalled by Haute Health | Haute Health | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS I | Prolifta Dietary Supplement Prolifta, 400mg/capsule recalled | Haute Health | Hidden Drug Ingredients | Nationwide |