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.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Majopa Industries Corporation
- Category
- Food — Dietary Supplement
- 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:
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