Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Product description
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Lot numbers, UPCs & expiration codes
All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
Where it was sold
Nationwide
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-0466-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 14, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 500 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SAINI TRADE INC
Original FDA data
Every field from FDA enforcement report D-0466-2025, exactly as published.
Show all FDA fields
- City
- Tempe
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96735
- Address
- 1405 N Scottsdale Rd
- Code information
- All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
- Postal code
- 85288-1714
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0466-2025
- Classification
- Class I
- Recalling firm
- SAINI TRADE INC
- Product quantity
- 500 boxes
- Reason for recall
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 14, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 11, 2025