FDA Drug recall D-0464-2025
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3
- FDA Drug
- Class I
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class I recall of MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3 by Saini Trade, citing marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0464-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-14 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Saini Trade |
| Distribution | US |
Product
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Reason
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Identifiers
| code_info | All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0464-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.