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.

26–50 of 547

  • SevereFDA (Drugs)·D-0206-2024·2024-01-03

    Supplement Capsules Recalled for Undeclared Sildenafil Content Nationwide

    Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.

    Product
    Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2024·2023-12-27

    Male Enhancement Capsules Recalled for Containing Unapproved Drug Ingredient

    THE ROCK male enhancement capsules are recalled because they contain Sildenafil, a pharmaceutical ingredient not approved for this product. The product was distributed in Florida, the Bahamas, and Turks & Caicos Islands.

    Product
    THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0138-2024·2023-12-13

    Dietary supplement recalled for unapproved drug status and pharmaceutical contamination

    Dr. Ergin's SugarMD glucose support capsules are recalled nationwide because they were marketed without FDA approval and are contaminated with the pharmaceutical ingredients metformin and glyburide. Approximately 32,117 units were distributed in the U.S.

    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2024·2023-12-06

    Reumo Flex caplets recalled for undeclared diclofenac content nationwide

    Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2024·2023-12-06

    Kuka Flex Forte caplets recalled for undeclared diclofenac and lack of FDA approval

    Botanical Be is recalling Kuka Flex Forte caplets nationwide because they contain undeclared diclofenac and were marketed without required FDA approval. All lots expire 12/12/2024.

    Product
    Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2024·2023-12-06

    FDA recalls Artri King tablets for undeclared diclofenac

    Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.

    Product
    Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2023·2023-09-20

    WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil

    WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.

    Product
    WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2023·2023-09-06

    Vegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil

    The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.

    Product
    Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2023·2023-05-10

    Unapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients

    DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.

    Product
    DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0572-2023·2023-05-10

    NUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients

    The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.

    Product
    NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0571-2023·2023-05-10

    Pro Power Knight Plus Capsule Recalled for Undeclared Pharmaceutical Ingredients

    Pro Power Knight Plus capsules contain undeclared sildenafil and tadalafil, prescription ingredients not listed on the label. The product was marketed as an unapproved drug and poses safety risks.

    Product
    Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0541-2023·2023-05-03

    CBD Metered Dose Inhaler Recalled for Marketing Without FDA Approval

    Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.

    Product
    CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2023·2023-03-08

    PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients

    The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.

    Product
    PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2023·2022-10-19

    Skincell Mole & Skin Corrector Serum Recalled Due to Unapproved Drug Status

    Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum because it was marketed without FDA approval. The affected product was distributed throughout the United States, Puerto Rico, and Canada.

    Product
    Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0008-2023·2022-10-19

    Skincell Mole & Skin Corrector Serum recalled as unapproved drug

    Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum. The product was marketed as a drug without FDA approval (NDA/ANDA).

    Product
    Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1350-2022·2022-08-10

    SUSTANGO supplement capsules recalled for undisclosed tadalafil content

    SUSTANGO capsules contain the undisclosed pharmaceutical ingredient tadalafil and were marketed without FDA approval. Approximately 750 cartons were distributed nationwide via Amazon.

    Product
    SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2022·2022-07-27

    Launch Sequence Aphrodisia Capsules recalled for undeclared tadalafil

    Launch Sequence Aphrodisia Capsules contain undeclared tadalafil, making them an unapproved drug. The recall involves 500 4-count tins distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2022·2022-07-27

    FDA Recalls Launch Sequence Euphoria Capsules for Undeclared Tadalafil

    Launch Sequence Euphoria Capsules have been recalled because the product contains undeclared tadalafil, an unapproved active ingredient. The capsules were distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1339-2022·2022-07-27

    Dietary Supplement Marketed as Unapproved Drug Recalled by FDA

    Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.

    Product
    Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1341-2022·2022-07-27

    Loud Muscle Science Recalls Unapproved Capsule Product Marketed as Aphrodisia

    Loud Muscle Science is recalling Launch Sequence Aphrodisia Capsules because they were marketed without FDA approval. The product was distributed nationwide in the USA and Canada.

    Product
    Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1340-2022·2022-07-27

    FDA Recalls Launch Sequence Euphoria Capsules as Unapproved Drug

    Launch Sequence Euphoria Capsules were marketed without FDA approval. Consumers should discontinue use immediately and contact the manufacturer.

    Product
    Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2022·2022-06-22

    Artri King Tablets Recalled Due to Undeclared Diclofenac

    Artri King Reforzado con Ortiga Omega 3 Tablets are being recalled for containing undeclared diclofenac and being marketed without FDA approval. The recall affects 1,308 bottles distributed nationwide.

    Product
    Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1159-2022·2022-06-22

    Artri King Reforzado con Ortiga Omega 3 Tablets Recalled as Unapproved Drug

    Walmart Inc is recalling Artri King Reforzado con Ortiga Omega 3 Tablets nationwide because the product was marketed as a drug without FDA approval. All lots are affected.

    Product
    Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1158-2022·2022-06-22

    Artri Ajo King Tablets Recalled for Unapproved Drug Claims

    Walmart is recalling all lots of Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets nationwide. The product was marketed without FDA approval based on unapproved labeling claims.

    Product
    Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0785-2022·2022-04-27

    FDA Recalls Pink Pussycat Sensual Enhancement Capsules for Undeclared Sildenafil

    Pink Pussycat Sensual Enhancement capsules are being recalled nationwide. The FDA found they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
    Category
    Drug
    Distribution
    Distributed nationwide