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Class I: serious health riskTerminated

Walmart Stores Avaphinal Maximum Male Enhancement Sexual Recall

Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per…

Walmart Stores · Bentonville, AR

Risk level
Class I
Reported by FDA
Mar 23, 2022
Recall ID
D-0725-2022
Check your lot numberHow we source this data

Summary

Walmart Stores recalled Avaphinal Maximum Male Enhancement Sexual starting Feb 9, 2022. The FDA classified it as Class I (serious health risk) and published enforcement report D-0725-2022 on Mar 23, 2022. Reason: 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. Status: Terminated.

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
E-Mail
Center classification date
Mar 29, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0725-2022, published Mar 23, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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