FDA Drugs recall ·
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0464-2025
- Date
- (initiated April 14, 2025)
- Company / brand
- Saini Trade Inc
1405 N Scottsdale Rd, Tempe, AZ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 500 boxes
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Why was it recalled?
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
Distribution
Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0464-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.