FDA recall D-0470-2024

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.

Distribution

USA Nationwide. The product was sold via Amazon Market Place.

Key facts

Status

Terminated

Initiation date

2024-02-12

Report date

2024-05-01

Termination date

2024-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fresh Meadows, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2024