MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, U
Summary
The FDA issued a Class I for MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distribu by SAINI TRADE INC. Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil..
Details
Source
Drug Recall
External ID
D-0464-2025
Action Date
2025-06-18
Status
Ongoing
Category
drug
Product Description
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Lot/Code Info: All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
Quantity Affected: 500 boxes
Reason for Recall
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-14
Company
Tempe, AZ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SAINI TRADE INC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SAINI TRADE INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SAINI TRADE INC have FDA actions?
SAINI TRADE INC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0464-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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