May 2025 FDA Recall Drug by Enshishixiangnishangmaoyouxiangongsi
D-0453-2025 - Marketed without approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Enshishixiangnishangmaoyouxiangongsi on May 6, 2025 for the product Drug. The FDA reported the reason for recall as marketed without approved nda/anda. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0453-2025

Reason for Recall
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Initiated
05-06-2025
Reported
06-04-2025
Quantity
600, 20-count cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96833
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
EnShiShiXiangNiShangMaoYouXianGongSi
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide Via Amazon Platform
Product Description About Product Description
Full technical description of the product.
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N

Batch or Lot Expiration Information

Lot# Lot: 250214PRO, Expiration Date: 02/14/2027.