CLASS I Drug recall · Reported 30 Jan 2019 · FDA Enforcement Report
5K Premium Enhancement capsule, 5000 mg blister card recalled
Happy Together is recalling 5K Premium Enhancement capsule, 5000 mg blister card, box of 30, Happy Together Inc. The recall was initiated on 8 Jan 2019 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-0388-2019
- FDA event ID
- 81913
- Recalling firm
- Happy Together, Boynton Beach, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Jan 2019
- FDA classified
- 22 Jan 2019
- Reported
- 30 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 8 Jan 2019 | Recall initiated by company | |
| 22 Jan 2019 | Classified by FDA | +14 days |
| 30 Jan 2019 | 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; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Product as listed by the FDA
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Where it was distributed
Product was sold over the internet
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Which lots are affected?
All lots within expiry
Where was it sold?
Product was sold over the internet
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.