The Recall Desk

Hazard

Unapproved Drug recalls

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

What the numbers show

Total
547
Critical
146
Severe
195
Most recent
2026-08-19

Of the 547 unapproved drug recalls we have scored against our rubric, 146 (27%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 195 (36%) 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 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.

351–375 of 547

  • CriticalFDA (Drugs)·D-0860-2016·2016-06-01

    Lipo Escultura capsules recalled for containing unapproved prescription drugs

    Lipo Escultura capsules are being recalled because they contain sibutramine and diclofenac, making them unapproved drugs rather than dietary supplements.

    Product
    LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0894-2016·2016-06-01

    FDA Recalls Unapproved Male Enhancement Product Sold Nationwide Online

    The FDA is recalling 'Bigger Longer More Time More Sperms' because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0902-2016·2016-06-01

    FDA Recalls Mojo Risen Distributed Without Approved New Drug Application

    R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0884-2016·2016-06-01

    FDA Recalls Black Ant Supplements Marketed Without Approval

    The FDA is recalling Black Ant supplements distributed by R Thomas Marketing, LLC because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0893-2016·2016-06-01

    FDA Recalls African Superman Supplements Marketed Without Approval

    R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0903-2016·2016-06-01

    Night Man capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Night Man capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0892-2016·2016-06-01

    FDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide

    R Thomas Marketing, LLC is recalling Zhong Hua Niu Bian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0901-2016·2016-06-01

    Man King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Man King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2016·2016-06-01

    FDA Recalls Bull Capsules Marketed Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2016·2016-06-01

    African Black Ant capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling African Black Ant capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2016·2016-06-01

    FDA Recalls Black Storm Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Black Storm capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0886-2016·2016-06-01

    Real Skill Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Real Skill capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0907-2016·2016-06-01

    FDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Zhen Gong Fu capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0891-2016·2016-06-01

    Bull's Genital Recalled for Marketing Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull's Genital capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0898-2016·2016-06-01

    Happy Passengers Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0906-2016·2016-06-01

    FDA Recalls Super Hard Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Super Hard capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0899-2016·2016-06-01

    Plant Vigra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Plant Vigra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0885-2016·2016-06-01

    Herb Viagra Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Herb Viagra because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0855-2016·2016-05-25

    Renovo Patch Recalled for Lack of Approval and Subpotency

    TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.

    Product
    Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1220-2016·2016-05-11

    Iowa Select Herbs Recalls Sassafras Root Bark Due to Misbranding

    Iowa Select Herbs LLC is recalling Sassafras Root Bark because it is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Sassparilla Smilax uti lis, www.iowaselectherbs.com, 7.5 fl. Oz.., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1135-2016·2016-05-11

    Iowa Select Herbs Recalls Acia Berry Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling 10 bottles of Acia Berry dietary supplement because the product is misbranded, an unapproved new drug, and an adulterated supplement.

    Product
    Iowa Select Herbs LLC, Acia Berry (Euterpe oleracea), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1223-2016·2016-05-11

    Iowa Select Herbs Recalls Scullcap Supplement Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 4 fl. oz. bottles of Scullcap (Scutellaria lateriflora) because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Scullcap (Scutellaria lateriflora), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2016·2016-05-11

    Iowa Select Herbs Recalls Propolis Supplement for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Propolis (Ligustrum lucidum) supplements because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Propolis (Ligustrum lucidum), 4 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1181-2016·2016-05-11

    Iowa Select Herbs Recalls Soursop Leaf Product for Misbranding

    Iowa Select Herbs LLC is recalling Graviola Leaf "Soursop" products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Graviola Leaf "Soursop" (Annona muricata), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1234-2016·2016-05-11

    Iowa Select Herbs Recalls Ziziphus Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling Ziziphus supplements because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Ziziphus (Zizyphus jujuba spinosa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide