Why it was recalled
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.
Product description
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
USA Nationwide. The product was sold via Amazon Market Place.
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-0470-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 12, 2024
- FDA report date
- May 1, 2024
- Quantity
- 400 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FA Online Inc
Original FDA data
Every field from FDA enforcement report D-0470-2024, exactly as published.
Show all FDA fields
- City
- Fresh Meadows
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94339
- Address
- 6520 180th St
- Code information
- All lots within expiry
- Postal code
- 11365-2140
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0470-2024
- Classification
- Class I
- Recalling firm
- FA Online Inc
- Product quantity
- 400 capsules
- Termination date
- Jun 13, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
- Distribution pattern
- USA Nationwide. The product was sold via Amazon Market Place.
- Recall initiation date
- Feb 12, 2024
- Initial firm notification
- Press Release
- Center classification date
- Apr 23, 2024