Why it was 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.
Product description
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Lot numbers, UPCs & expiration codes
Lot # #18520168, Exp. date 09/30/2026 .
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1180-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 25, 2023
- FDA report date
- Sep 20, 2023
- Quantity
- 300 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hua Da Trading, Inc. dba Wefun Inc.
Original FDA data
Every field from FDA enforcement report D-1180-2023, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 92979
- Address
- 6306 20th Ave
- Code information
- Lot # #18520168, Exp. date 09/30/2026 .
- Postal code
- 11204-3049
- Report date
- Sep 20, 2023
- Product type
- Drugs
- Recall number
- D-1180-2023
- Classification
- Class I
- Recalling firm
- Hua Da Trading, Inc. dba Wefun Inc.
- Product quantity
- 300 cartons
- Termination date
- Apr 30, 2026
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 25, 2023
- Initial firm notification
- Press Release
- Center classification date
- Sep 29, 2023