FDA Recall D-1180-2023
Hua Da Trading, Inc. dba Wefun Inc. · Brooklyn, NY
Class I — life-threatening Terminated 979 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-1180-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2023-08-25
- Classified by FDA Center
- 2023-09-29
- FDA published
- 2023-09-20
- Terminated
- 2026-04-30
- Recalling firm
- Hua Da Trading, Inc. dba Wefun Inc.
- Firm location
- Brooklyn, NY