FDA Drug recall · Reported June 18, 2025
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Saini Trade INC recalled Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; H… - a critical-severity action.
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; H… was recalled by Saini Trade INC in June 18, 2025. Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared pr…. Check the official notice for the remedy. Verify recall #D-0463-2025 with the FDA Drug before acting.
The recall
Saini Trade INC issued this critical-severity FDA Drug recall-Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared pr….
- Critical
- severity level
- Class I
- classification
- June 18, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0463-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,014 dietary supplements recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Reason for recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0463-2025 |
| Date reported | June 18, 2025 |
| Date initiated | April 14, 2025 |
| Recalling firm | Saini Trade INC |
| Firm location | Tempe, AZ |
| Affected scope | 3000 boxes |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0463-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Dietary Supplements · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with Goody King Magnetic Building Cubes and Blocks Recalled Due … → · All Dietary Supplements recalls
Methodology · Corrections · Archive as of August 2026