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Class I: serious health riskTerminated

Epic Products Euphoric Premium Male Performance Enhancer Recall

Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards

Epic Products, LLC · Overland Park, KS

Risk level
Class I
Reported by FDA
Nov 21, 2018
Recall ID
D-0288-2019
Check your lot numberHow we source this data

Summary

Epic Products recalled Euphoric Premium Male Performance Enhancer starting Apr 16, 2018. The FDA classified it as Class I (serious health risk) and published enforcement report D-0288-2019 on Nov 21, 2018. Reason: Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.

Product description

Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0288-2019
Classification
Class I
Status
Terminated
Recall initiated
Apr 16, 2018
FDA report date
Nov 21, 2018
Quantity
a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Epic Products, LLC

Original FDA data

Every field from FDA enforcement report D-0288-2019, exactly as published.

Show all FDA fields
City
Overland Park
State
KS
Status
Terminated
Country
United States
Event ID
79842
Address
11730 W 135th St
Address (line 2)
#224
Code information
All lots
Postal code
66221-9395
Report date
Nov 21, 2018
Product type
Drugs
Recall number
D-0288-2019
Classification
Class I
Recalling firm
Epic Products, LLC
Product quantity
a) 106,329 cards; b) 109,725 bottles; c) 28,644 bottles
Termination date
Oct 3, 2024
Reason for recall
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
Distribution pattern
Nationwide in the USA
Recall initiation date
Apr 16, 2018
Initial firm notification
Press Release
Center classification date
Nov 30, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0288-2019, published Nov 21, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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