The Recall Desk
SevereFDA (Food)·F-3245-2015·Announced 2015-09-30

Majopa Graviola Extract Recalled for Unapproved Drug Claims

Majopa Industries is recalling 500 bottles of Graviola Extract sold in Puerto Rico because the label made unapproved drug claims, including cancer treatment.

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 agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

Majopa Industries Corporation is recalling 500 bottles of Graviola Extract, 1 FL Oz (30 ml), Original Formula. The product was manufactured in Puerto Rico and distributed only in Puerto Rico. The code information provided is 02/2020.

The recall was initiated because the dietary supplement was promoted for conditions that caused the products to be classified as drugs under the Federal Food, Drug, and Cosmetic (FD&C) Act. The product label contained claims stating that extracts from Graviola leaves can produce acetogenins effective in the treatment of cancer cells, act as an antibiotic against cancer cells, and serve as a cellular protector, anti-tumorous, antiviral, digestive stimulant, immune system strengthener, antifungal, and tranquilizer.

Consumers who purchased this product should stop using it and contact the manufacturer for further instructions. The recall is limited to the 500 bottles distributed in Puerto Rico.

The recalled product

Product
Label reads in part as: "GRAVIOLA EXTRACT***1 FL Oz (30 ml)*** ORIGINAL FORMULA***Manufactured by: Majopa Industries Corp.*** PRODUCT OF PUERTO RICO,USA". Drug claims in the product label are as follows: "Researchers have found that Extracts from Graviola leaves can produce ac
Affected units
500

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 (1)

  • 02/2020

Distribution

Distributed in 1 state: