The Recall Desk

Hazard

Unapproved New Drug recalls

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

What the numbers show

Total
7
Critical
4
Severe
2
Most recent
2020-04-15

Of the 7 unapproved new drug recalls we have scored against our rubric, 4 (57%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (29%) 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 new drug 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.

1–7 of 7

  • ModerateFDA (Drugs)·D-1120-2020·2020-04-15

    Herbal Doctor Remedies Recalls Detoxin-S Capsules Due to CGMP Deviations

    Herbal Doctor Remedies is recalling Detoxin-S 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Detoxin-S, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1480-2018·2018-05-30

    FDA Recalls Nature's Only Choice B17 Apricot Extract Dietary Supplement

    Nature's Only Choice is recalling B17 Bitter Raw Apricot Extract Amygdalin dietary supplements because the product is considered an unapproved new drug.

    Product
    Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1223-2014·2014-04-16

    FDA Recalls Vicerex Male Sexual Enhancer for Undeclared Tadalafil

    The FDA is recalling Vicerex male sexual enhancer capsules because laboratory analysis found undeclared tadalafil, an unapproved drug ingredient.

    Product
    Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1224-2014·2014-04-16

    FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil

    The FDA is recalling Black Ant dietary supplements because laboratory analysis found they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction.

    Product
    Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 402
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1154-2014·2014-03-19

    CTV Best Group Recalls BEST Slim Weight Loss Pills

    CTV Best Group is recalling BEST Slim weight loss pills because they contain the undeclared drug sibutramine, making them unapproved new drugs.

    Product
    BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1047-2014·2014-02-05

    eXtenZone capsules recalled for containing unapproved drug ingredients

    SS Wholesale Inc. is recalling eXtenZone capsules because FDA analysis found undeclared desmethyl carbondenafil and dapoxetine, making the product an unapproved new drug.

    Product
    eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1045-2014·2014-02-05

    FDA Recalls Rhino 5 Capsules Containing Unapproved Drug Ingredients

    FDA is recalling Rhino 5 capsules marketed as a dietary supplement because they contain undeclared desmethyl carbondenafil and dapoxetine, making them unapproved new drugs.

    Product
    Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
    Category
    Drug
    Distribution
    1 state