Recalls / Class I
Class ID-0465-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
- Affected lot / code info
- All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Recalling firm
- Firm
- SAINI TRADE INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1405 N Scottsdale Rd, Tempe, Arizona 85288-1714
Distribution
- Quantity
- 300 boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-04-14
- FDA classified
- 2025-06-11
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0465-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.