FDA Recall D-0470-2024
FA Online Inc · Fresh Meadows, NY
Class I — life-threatening Terminated 122 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Reason for recall
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Recall record
- Recall number
D-0470-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA Nationwide. The product was sold via Amazon Market Place.
- Recall initiated
- 2024-02-12
- Classified by FDA Center
- 2024-04-23
- FDA published
- 2024-05-01
- Terminated
- 2024-06-13
- Recalling firm
- FA Online Inc
- Firm location
- Fresh Meadows, NY