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.

76–100 of 547

  • CriticalFDA (Drugs)·D-0634-2021·2021-06-30

    PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients

    PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.

    Product
    PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0633-2021·2021-06-30

    PremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination

    PremierZEN Gold 7000 capsules are recalled nationwide because the product contains undisclosed pharmaceutical ingredients Sildenafil and Tadalafil and was marketed without FDA approval.

    Product
    PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2021·2021-06-30

    maXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants

    The FDA is recalling maXXzen Platinum 12000 capsules distributed nationwide because the product was marketed without an approved application and contains undisclosed pharmaceutical ingredients (Sildenafil and Tadalafil).

    Product
    maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0383-2021·2021-05-26

    FDA Recalls Triple SupremeZen Plus 3500 for Unapproved Tadalafil

    Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0368-2021·2021-05-12

    QMart Recalls Imperial Gold 2000 Male Enhancement Capsules

    QMart is recalling Imperial Gold 2000 male sexual performance enhancement capsules because FDA analysis found undeclared tadalafil and/or sildenafil.

    Product
    IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1627-2020·2020-10-07

    pH-D Boric Acid Vaginal Suppositories Recalled for Lack of FDA Approval

    pH-D Feminine Health is recalling Boric Acid Vaginal Suppositories because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1595-2020·2020-09-30

    Protein Shoppe Recalls Red-E Tablets Tainted With Sildenafil

    The Protein Shoppe is recalling Red-E Tablets found to contain sildenafil, an unapproved drug for erectile dysfunction. The product was marketed without FDA approval.

    Product
    Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1586-2020·2020-09-30

    Leafree Hand Sanitizer Recalled for Lacking FDA Approval

    Corgiomed LLC is recalling Leafree Instant Hand Sanitizer because it was marketed without FDA approval and labeled as edible alcohol.

    Product
    Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, Mc
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1574-2020·2020-09-09

    FDA Recalls Skin Guard 24 Hand Sanitizing Towelettes for Unapproved Methanol

    SG24 LLC is recalling Skin Guard 24 hand sanitizing towelettes because they contain unapproved methanol and lack FDA approval.

    Product
    Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1472-2020·2020-09-09

    Sundial Blue Vervain Herbal Product Recalled for Unapproved Drug Claims

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1572-2020·2020-09-09

    SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content

    SG24 LLC is recalling SkinGuard 24 Hand Sanitizer because it is an unapproved new drug containing methanol.

    Product
    SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1467-2020·2020-09-09

    Sundial Blood Leaf Herbal Product Recalled as Unapproved Drug

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLOOD LEAF***1oz.***USES: SUPPLIES IRON, FOOD SUPPLEMENT***ANEMIA***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1573-2020·2020-09-09

    Skin Guard 24 Hand Sanitizer Recalled for Unapproved Methanol Content

    SG24 LLC is recalling Skin Guard 24 All-Day Hand Sanitizer pens because they are labeled to contain methanol, making them unapproved new drugs.

    Product
    Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1485-2020·2020-09-09

    Sundial Herbal Products Recalls Palo De Brazil Wood Under FDA Injunction

    Sundial Herbal Products is recalling Palo De Brazil Wood in New York because the product is misbranded and deemed an unapproved drug.

    Product
    "***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1571-2020·2020-09-09

    SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content

    SG24 LLC is recalling SkinGuard 24 All-Day Hand Sanitizer because it is an unapproved new drug containing methanol.

    Product
    SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1473-2020·2020-09-09

    Sundial Pimento Herbal Product Recalled for Misbranding and Unapproved Drug Claims

    Sundial Herbal Products is recalling Pimento herbal products under a permanent injunction. The items are misbranded and deemed unapproved drugs due to specific labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***PIMENTO***1 oz.***USES: STIMULANT, DIABETES, WORMS, PREVENTS STROKES, REDUCES TOBACCO URGE, WARMS BODY***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1451-2020·2020-09-09

    Sundial Herbal Products Recalls Cerasee Herbal Product for Misbranding

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

    Product
    "SUNDIAL Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***CERASEE***1 oz.***USES: DIABETES, HYPERTENSION, WORMS, DYSENTERY, MALARIA, BLOOD PURIFIER"; packaged in clear zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1441-2020·2020-09-09

    Sundial Princess Almaz Spiced Tea Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sundial Princess Almaz Spiced Tea because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    SUNDIAL PRINCESS ALMAZ Traditional ETHIOPIAN Organic SPICED TEA; "***Improves circulation***eliminates gas stomach griping & cramps. Relieves acid reflux, coughs, flu, hay fever, allergies, breaks up mucus and fights infection***" packaged in a breathable-type bag within a box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1460-2020·2020-09-09

    Sundial Sea Moss Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Sea Moss/Irish Moss products because they are misbranded and deemed unapproved drugs based on labeling claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERB***SEA MOSS/IRISH MOSS***2oz.***USES: IODINE, BREAKS UP FAT & MUCOUS, ADD, ULCERS, CALCIUM, THYROID, DETOX***"; packaged in clear plastic zip-top bags
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1448-2020·2020-09-09

    Sundial Herbal Products Recalls Mitmitta Cayenne Pepper Product

    Sundial Herbal Products is recalling Mitmitta (Cayenne Pepper) because it is misbranded and deemed an unapproved drug due to labeling claims.

    Product
    Mitmitta (Cayenne Pepper); "Traditional Uses: Prevents heart attacks, and lowers high blood pressure, stops internal bleeding, Heals ulcers and pains there of: Improves circulation, thins blood and keeps it moving***"
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1493-2020·2020-09-09

    Sundial Herbal Asthma Formula Recalled as Unapproved Drug

    Sundial Herbal Products is recalling its Traditional Herbal Formula for Asthma because it is an unapproved drug with misbranded labeling.

    Product
    "SUNDIAL***TRADITIONAL HERBAL FORMULA***ASTHMA***" packaged in boxes
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1466-2020·2020-09-09

    Sundial Herbal Products Recalls Mojo Bush Under FDA Injunction

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

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***MOJO BUSH***1 oz.***USES: SKIN, BLOOD PURIFIER, STOMACH & INTESTINAL CLEANSER, REMOVES PARASITES***"; packaged in clear plastic zip-top bags
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1487-2020·2020-09-09

    Sundial Bread Nut Herbal Product Recalled for Unapproved Drug Claims

    Sundial Herbal Products is recalling Bread Nut herbal products under a permanent injunction because the labeling makes unapproved drug claims.

    Product
    "SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BREAD NUT***1oz.***USES: CHOLESTEROL, OMEGA 3, BI POLAR, ANTIOXIDANT, BUILDS BONES, ACNE***"
    Category
    Food
    Distribution
    1 state