The Recall Desk
SevereFDA (Drugs)·D-0725-2022·Announced 2022-03-23

Avaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug

Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I recall. According to the severity rubric, FDA Class I recalls receive a minimum score of 4 regardless of other factors. The presence of an undeclared pharmaceutical ingredient in an unapproved drug product presents a significant safety and regulatory concern.

Plain-English summary

Walmart Stores is recalling Avaphinal Maximum Male Enhancement Sexual Pills, packaged in 10-capsule cartons with 2000 MG labeling. The product was distributed nationwide through www.walmart.com.

The product was found to contain undeclared sildenafil, an ingredient approved by the FDA for male sexual enhancement treatment in approved medications. Because sildenafil is not declared on the label, the product is classified as an unapproved drug and does not meet FDA requirements for marketing and safety.

Consumers who have purchased this product should stop using it immediately. The affected lot is DK1027 with an expiration date of 08/01/2023. For questions or to report adverse effects, consumers should contact Walmart or the FDA.

The recalled product

Product
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Manufacturer
Walmart Stores
Hazard
  • undeclared-sildenafil
  • unapproved-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: DK1027
  • Exp 08/01/2023

Distribution

Distributed nationwide across the United States.