Why it was recalled
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Product description
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
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-0003-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 12, 2024
- FDA report date
- Oct 9, 2024
- Quantity
- 729
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Supercore Products Group Inc.
Original FDA data
Every field from FDA enforcement report D-0003-2025, exactly as published.
Show all FDA fields
- City
- Atlanta
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94949
- Address
- 230 Peachtree St Nw
- Address (line 2)
- Ste 2200
- Code information
- All lots
- Postal code
- 30303-1534
- Report date
- Oct 9, 2024
- Product type
- Drugs
- Recall number
- D-0003-2025
- Classification
- Class I
- Recalling firm
- Supercore Products Group Inc.
- Product quantity
- 729
- Reason for recall
- Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
- Distribution pattern
- Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)
- Recall initiation date
- Jul 12, 2024
- Initial firm notification
- Press Release
- Center classification date
- Oct 2, 2024