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.

201–225 of 547

  • ModerateFDA (Drugs)·D-1113-2020·2020-04-15

    Herbal Doctor Remedies Recalls Blood Clot Purger for Misbranding

    Herbal Doctor Remedies is recalling Blood Clot Purger because the product is misbranded as an unapproved new drug.

    Product
    Blood Clot Purger, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1115-2020·2020-04-15

    Herbal Doctor Remedies Recalls De-Fibroidin Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling De-Fibroidin 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    De-Fibroidin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1136-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes V Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes V Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the US and internationally.

    Product
    Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1163-2020·2020-04-15

    Herbal Doctor Remedies Recalls Stomach Cleanser Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Stomach Cleanser capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1135-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes V Balm for CGMP Deviations

    Herbal Doctor Remedies is recalling Herpes V Balm because the product was found to be misbranded as an unapproved new drug.

    Product
    Herpes V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1139-2020·2020-04-15

    Herbal Doctor Remedies Recalls Immune-2100 Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Immune-2100 500mg capsules because they were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Immune-2100, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1134-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Soap for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Herpes Soap because the product is misbranded as an unapproved new drug. The soap was sold online in the US and internationally.

    Product
    Herpes Soap, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1150-2020·2020-04-15

    Herbal Doctor Remedies Recalls Phlegm Off Capsules Due to Unapproved Status

    Herbal Doctor Remedies is recalling Phlegm Off capsules because the products are misbranded as unapproved new drugs.

    Product
    Phlegm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1169-2020·2020-04-15

    Herbal Doctor Remedies Recalls Unapproved Vigo-XXX Capsules

    Herbal Doctor Remedies is recalling Vigo-XXX 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Vigo-XXX, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1155-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-8 Capsules Due to Unapproved Drug Status

    Herbal Doctor Remedies is recalling Reman-8 capsules because the products are misbranded as unapproved new drugs.

    Product
    Reman-8, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1156-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-AP Capsules for CGMP Deviations

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

    Product
    Reman-AP, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1146-2020·2020-04-15

    Herbal Doctor Remedies Recalls New Life Due to Unapproved New Drug Status

    Herbal Doctor Remedies is recalling New Life because the product is misbranded as an unapproved new drug. The recall covers all lots within expiry sold online in the US and internationally.

    Product
    New Life, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1125-2020·2020-04-15

    Fungo Balm Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug.

    Product
    Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1130-2020·2020-04-15

    Herbal Doctor Remedies Recalls Hair Back Lotion for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hair Back Lotion because the product is misbranded as an unapproved new drug. The lotion was sold online in the U.S. and internationally.

    Product
    Hair Back Lotion, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1154-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-6 Capsules Due to CGMP Deviations

    Herbal Doctor Remedies is recalling Reman-6 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Reman-6, 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 (Drugs)·D-0800-2020·2020-01-29

    Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval

    Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0654-2020·2020-01-22

    FDA Recalls Unapproved Bull Platinum 30000 Capsules Containing Tadalafil

    Motto International Corp is recalling Bull Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, a prescription drug, and it was marketed without an approved NDA or ANDA.

    Product
    Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0196-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 25 bottles of Biogenyx CBD Oil because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0193-2020·2019-11-13

    Basic Reset CBD Product Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 98 bottles of CBD Reset 750 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0191-2020·2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 554 bottles of CBD Reset 750 oil because the product was marketed without an approved FDA application.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0192-2020·2019-11-13

    Basic Reset CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 598 bottles of CBD Reset 750 True Full Spectrum Cinnamon because the product was marketed without an approved NDA or ANDA.

    Product
    Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0189-2020·2019-11-13

    Basic Reset Nuovi Skin Toner Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0197-2020·2019-11-13

    Biogenyx CBD Oil Recalled for Lack of FDA Approval

    Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075
    Category
    Drug
    Distribution
    2 states