PlainRecalls
FDA Drug Critical Class I Completed

WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5

Reported: September 20, 2023 Initiated: August 25, 2023 #D-1180-2023

Product Description

WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5

Reason for Recall

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Details

Units Affected
300 cartons
Distribution
Distributed Nationwide in the USA
Location
Brooklyn, NY

Frequently Asked Questions

What product was recalled?
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5. Recalled by Hua Da Trading, Inc. dba Wefun Inc.. Units affected: 300 cartons.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2023. Severity: Critical. Recall number: D-1180-2023.