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Class I: serious health riskTerminated

Stiff Boy The Beast Recall

The Beast, The Beast can be taken under the situation of Heart disease and even after d…

Stiff Boy LLC · Englewood, NJ

Risk level
Class I
Reported by FDA
Jun 5, 2019
Recall ID
D-1321-2019
Check your lot numberHow we source this data

Summary

Stiff Boy recalled The Beast starting May 6, 2019. The FDA classified it as Class I (serious health risk) and published enforcement report D-1321-2019 on Jun 5, 2019. Reason: Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.

Product description

The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide

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-1321-2019
Classification
Class I
Status
Terminated
Recall initiated
May 6, 2019
FDA report date
Jun 5, 2019
Quantity
1000 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
Stiff Boy LLC

Original FDA data

Every field from FDA enforcement report D-1321-2019, exactly as published.

Show all FDA fields
City
Englewood
State
NJ
Status
Terminated
Country
United States
Event ID
82704
Address
90 Highwood Ave
Code information
All lots
Postal code
07631-1717
Report date
Jun 5, 2019
Product type
Drugs
Recall number
D-1321-2019
Classification
Class I
Recalling firm
Stiff Boy LLC
Product quantity
1000 boxes
Termination date
Sep 16, 2025
Reason for recall
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Voluntary / mandated
Voluntary: Firm initiated
Product description
The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
Distribution pattern
Nationwide
Recall initiation date
May 6, 2019
Initial firm notification
Press Release
Center classification date
Jun 5, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1321-2019, published Jun 5, 2019. 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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