Saini Trade Inc drug recall: Male Ultra
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96735
- Recall initiated
- Apr 14, 2025
- Classified by FDA
- Jun 11, 2025
- Posted in Enforcement Report
- Jun 18, 2025
- Recalling firm
- SAINI TRADE INC
- Firm location
- Tempe, AZ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 5
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 14, 2025. FDA classified it 58 days later, on Jun 11, 2025. This recall event covers 5 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide
Recalled products (5)
D-0463-2025 Class I Ongoing
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Codes / lots: All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027
Quantity: 3000 boxes
D-0464-2025 Class I Ongoing
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Codes / lots: All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
Quantity: 500 boxes
D-0465-2025 Class I Ongoing
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Codes / lots: All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
Quantity: 300 boxes
D-0466-2025 Class I Ongoing
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Codes / lots: All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
Quantity: 500 boxes
D-0467-2025 Class I Ongoing
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Codes / lots: All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Quantity: 300 boxes
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96735
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.