FDA Recall D-0725-2022
Walmart Stores · Bentonville, AR
Class I — life-threatening Terminated 296 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
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.
Recall record
- Recall number
D-0725-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA via www.walmart.com
- Recall initiated
- 2022-02-09
- Classified by FDA Center
- 2022-03-29
- FDA published
- 2022-03-23
- Terminated
- 2022-12-02
- Recalling firm
- Walmart Stores
- Firm location
- Bentonville, AR