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Recall Observatory FDA recall evidence

Drug product

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

D-1180-2023

August 25, 2023

Class I

Product summary

Firm
Hua Da Trading, Inc. dba Wefun Inc.
Event
Event 92979
Status
Terminated
Classification
Class I
Quantity
300 cartons
Official record key
drug-enforcement:D-1180-2023

Official wording

Reason: 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.

Code information: Lot # #18520168, Exp. date 09/30/2026 .

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.