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.

151–175 of 547

  • ModerateFDA (Food)·F-1478-2020·2020-09-09

    Sundial Trumpet Leaf Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Trumpet Leaf herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***TRUMPET LEAF***1 oz.***USES: DIABETES, ASTHMA, CONGESTION, SKIN BATH, ULCERS, SORES, PARKINSON'S DISEASE, KIDNEY***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1465-2020·2020-09-09

    Sundial African Fever Bush Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling African Fever Bush under a permanent injunction because the product is misbranded and deemed an unapproved drug based on its labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***African Fever Bush***1oz***USES: FEVER, WORMS IN CHILDREN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1479-2020·2020-09-09

    Sundial White Jointa Herbal Product Recalled for Misbranding

    Sundial Herbal Products is recalling White Jointa herbal products under a permanent injunction because the items are misbranded and deemed unapproved drugs.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***WHITE JOINTA***1 oz.***USES: NERVES, COLD, ASTHMA, BRONCHITIS, MUCOUS FEVER MENSTRUAL PROBLEMS***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1477-2020·2020-09-09

    Sundial Quassia Wood Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Quassia Wood under a court order because the product is misbranded and considered an unapproved drug due to its labeling.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***QUASSIA WOOD***2 oz.***USES: ALCOHOLISM, LIVER, STOMACH COMPLAINTS, DIGESTIVE SYSTEM, KILLS LICE & PARASITES***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1456-2020·2020-09-09

    Sundial Mango Leaf Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Mango Leaf herbal products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MANGO LEAF***1 oz.***USES: KIDNEY STONES, HIGH BLOOD PRESSURE, RELATED TO NERVOUS CONDITIONS***"
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1329-2020·2020-07-01

    BIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials

    BIOTA Biosciences is recalling sterile Cannabidiol and Curcumin vials due to lack of sterility assurance and lack of FDA approval.

    Product
    Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1112-2020·2020-04-15

    FDA Recalls Bleeding Stop for Unapproved New Drug Status

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

    Product
    Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1140-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lipidtrol Capsules for CGMP Deviations

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

    Product
    Lipidtrol, 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-1174-2020·2020-04-15

    Herbal Doctor Remedies Recalls Thyro-H Capsules for CGMP Deviations

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

    Product
    Thyro-H, 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-1133-2020·2020-04-15

    Herbal Doctor Remedies Recalls Herpes Off Due to Unapproved New Drug Status

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

    Product
    Herpes Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1121-2020·2020-04-15

    Dragon Pain Balm Recalled for Being an Unapproved New Drug

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

    Product
    Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1131-2020·2020-04-15

    FDA Recalls Hernia Off for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Hernia Off because the product is misbranded as an unapproved new drug.

    Product
    Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1116-2020·2020-04-15

    Herbal Doctor Remedies Recalls Dermamycin Capsules for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Dermamycin 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Dermamycin, 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-1123-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fire Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Fire Off 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Fire 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-1114-2020·2020-04-15

    Herbal Doctor Remedies Recalls Cellulite Off for CGMP Deviations

    Herbal Doctor Remedies is recalling Cellulite Off because the product was found to be misbranded as an unapproved new drug.

    Product
    Cellulite Off, 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-1105-2020·2020-04-15

    Herbal Doctor Remedies Recalls Acupuncture Products for Misbranding

    Herbal Doctor Remedies is recalling acupuncture products sold online in the US and internationally because they are misbranded as unapproved new drugs.

    Product
    Acupuncture, 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-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-1141-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lump Shrinker Capsules for Misbranding

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

    Product
    Lump Shrinker, 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-1118-2020·2020-04-15

    Herbal Doctor Remedies Recalls DeTensin Ex for Unapproved New Drug Status

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

    Product
    DeTensin Ex, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states