CLASS I ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Male Ultra Pro, Unleash Your Force recalled by Saini Trade
Saini Trade is recalling Male Ultra Pro, Unleash Your Force 2 per, distributed nationwide in the US. The recall was initiated on 14 Apr 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0467-2025
- FDA event ID
- 96735
- Recalling firm
- Saini Trade, Tempe, AZ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 14 Apr 2025
- FDA classified
- 11 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
Timeline
| 14 Apr 2025 | Recall initiated by company | |
| 11 Jun 2025 | Classified by FDA | +58 days |
| 18 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Product as listed by the FDA
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Which lots are affected?
All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 96735This product is part of a recall event; the main page for the event is Electro Buzz, Dietary Supplement recalled by Saini Trade.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Electro Buzz, Dietary Supplement recalled by Saini Trade | Saini Trade | Labeling Errors | Nationwide | |
| CLASS I | Ultra Armor, My Armor My Power, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide | |
| CLASS I | Malextra, Recharge with Extra, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide | |
| CLASS I | Male Ultra, Unleash Your Force, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide |
More recalls from Saini Trade
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Male Ultra, Unleash Your Force, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide |
| Drug | CLASS I | Malextra, Recharge with Extra, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide |
| Drug | CLASS I | Ultra Armor, My Armor My Power, Dietary Supplement recalled | Saini Trade | Labeling Errors | Nationwide |
| Drug | CLASS I | Electro Buzz, Dietary Supplement recalled by Saini Trade | Saini Trade | Labeling Errors | Nationwide |