The Recall Desk

Hazard

Unapproved Drug Claims recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2020-12-02

Of the 2 unapproved drug claims recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved drug claims recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–2 of 2

  • ModerateFDA (Drugs)·D-0107-2021·2020-12-02

    Fusion Health Immune Boost Recalled for Marketing Without FDA Approval

    Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost because the product was marketed with drug claims without an approved NDA or ANDA.

    Product
    Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3245-2015·2015-09-30

    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.

    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
    Category
    Food
    Distribution
    1 state