Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product description
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Lot numbers, UPCs & expiration codes
Lot: DK1027, Exp 08/01/2023
Where it was sold
Nationwide in the USA via www.walmart.com
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-0725-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 9, 2022
- FDA report date
- Mar 23, 2022
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walmart Stores
Original FDA data
Every field from FDA enforcement report D-0725-2022, exactly as published.
Show all FDA fields
- City
- Bentonville
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 89686
- Address
- 805 Moberly Ln
- Code information
- Lot: DK1027, Exp 08/01/2023
- Postal code
- 72716-0560
- Report date
- Mar 23, 2022
- Product type
- Drugs
- Recall number
- D-0725-2022
- Classification
- Class I
- Recalling firm
- Walmart Stores
- Product quantity
- unknown
- Termination date
- Dec 2, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
- Distribution pattern
- Nationwide in the USA via www.walmart.com
- Recall initiation date
- Feb 9, 2022
- Initial firm notification
- Center classification date
- Mar 29, 2022