FDA Recall D-1321-2019
Stiff Boy LLC · Englewood, NJ
Class I — life-threatening Terminated 2325 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
Reason for recall
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Recall record
- Recall number
D-1321-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2019-05-06
- Classified by FDA Center
- 2019-06-05
- FDA published
- 2019-06-05
- Terminated
- 2025-09-16
- Recalling firm
- Stiff Boy LLC
- Firm location
- Englewood, NJ