Male Ultra Pro recall
FDA recall D-0467-2025 · initiated Apr 14, 2025
SAINI TRADE INC recalled Male Ultra Pro in Apr 2025 — an FDA Class I recall (D-0467-2025) because Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 300 boxes
Details
- Product
- Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
- Recalling company
- SAINI TRADE INC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Apr 14, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Male Ultra Pro recalled?
- SAINI TRADE INC recalled Male Ultra Pro in Apr 2025 — an FDA Class I recall (D-0467-2025) because Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Male Ultra Pro recalled?
- Per the FDA enforcement record, the reason for recall D-0467-2025 was: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Is a recalled Male Ultra Pro dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Male Ultra Pro are affected?
- Distributed: Nationwide. The recall covers these lots — All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0467-2025.