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.

51–75 of 547

  • SevereFDA (Drugs)·D-0725-2022·2022-03-23

    Avaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug

    Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.

    Product
    Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2022·2022-03-02

    RISE UP RED EDITION Capsules recalled for undeclared tadalafil

    RISE UP RED EDITION Capsules, 650 mg, have been recalled because they contain undeclared tadalafil, an ingredient found in FDA-approved male sexual enhancement products. The product is an unapproved drug and was distributed nationwide via Amazon Marketplace.

    Product
    RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0638-2022·2022-02-23

    RED MAMMOTH 400 mg Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    RED MAMMOTH capsules, 400 mg (Lot # DK1027, Exp. 08/01/2023) are being recalled because they contain undeclared sildenafil and tadalafil, making them an unapproved drug marketed without FDA authorization.

    Product
    RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0630-2022·2022-02-23

    THE RED PILL EXTRA STRENGTH Capsules Recalled for Undeclared Tadalafil

    THE RED PILL EXTRA STRENGTH 800 mg capsules are being recalled because they contain undeclared tadalafil, an active ingredient in FDA-approved sexual-enhancement medications. The product was marketed and distributed as an unapproved drug nationwide via Amazon.

    Product
    THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0631-2022·2022-02-23

    365 SKINNY High Intensity Capsules Recalled for Undeclared Sibutramine

    Je Dois Lavoir LLC is recalling 365 SKINNY High Intensity Capsules (600 mg, 30-count bottles) because the product contains undeclared sibutramine, a drug previously withdrawn from the US market due to safety concerns.

    Product
    365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0562-2022·2022-02-23

    MAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients

    MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.

    Product
    MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0563-2022·2022-02-23

    MAC DADDY PURPLE Capsules Recalled for Undeclared Drug Ingredients

    ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.

    Product
    MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0561-2022·2022-02-16

    HARD DAWN Rise and Shine Capsules Recalled for Undisclosed Tadalafil

    HARD DAWN Rise and Shine capsules (500 mg) are being recalled because they contain tadalafil, an FDA-approved drug, without proper approval or labeling. The product was sold nationwide via Amazon.

    Product
    HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0557-2022·2022-02-16

    MegMan Performance Booster capsules recalled for undeclared tadalafil

    Junp Hydration LLC is recalling MegMan Performance Booster 800 mg capsules because the product contains undeclared tadalafil, an active pharmaceutical ingredient not listed on the label, making it an unapproved drug.

    Product
    MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0363-2022·2022-01-05

    kleantouch Hand Sanitizer recalled for methanol contamination

    Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.

    Product
    kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0298-2022·2022-01-05

    Klean Touch Hand Sanitizer Recalled: Unapproved Methanol-Containing Drug

    Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) in 55-gallon drums because the product contains methanol and was marketed without FDA approval as a new drug.

    Product
    Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0001-2022·2021-10-13

    ALPHA MALE+ Male Enhancer Fruit Chew Strips Recalled for Unapproved Drug

    ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.

    Product
    ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0819-2021·2021-09-29

    X Rated Honey For Men Recalled for Undisclosed Tadalafil

    Phe Inc is recalling X Rated Honey For Men packets nationwide because the product contains Tadalafil and was marketed without FDA approval. Consumers should stop use immediately.

    Product
    X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0797-2021·2021-09-22

    Hydro Pineapple Burn Max Health Supplement Recalled for Undeclared Sibutramine

    Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2021·2021-09-01

    Miss Slim capsules recalled for unapproved marketing distribution

    HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).

    Product
    Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0686-2021·2021-07-28

    Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil

    Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.

    Product
    Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0662-2021·2021-07-28

    Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients

    Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.

    Product
    Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0663-2021·2021-07-28

    Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients

    Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.

    Product
    Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0685-2021·2021-07-28

    Shogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.

    Product
    Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2021·2021-07-28

    Thumbs Up 7 White Capsules Recalled for Undeclared Pharmaceutical Ingredients

    Nuri Trading LLC is recalling Thumbs Up 7 White 11K capsules nationwide because they contain undeclared prescription drug ingredients (tadalafil, sildenafil, and vardenafil) and lack FDA approval.

    Product
    Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2021·2021-07-28

    Thumbs Up 7 Red Capsules Recalled for Undeclared Active Pharmaceutical Ingredients

    Ummzy LLC is recalling Thumbs Up 7 Red 70K capsules because they contain undeclared tadalafil and/or sildenafil and vardenafil, making them unapproved drugs with unestablished safety and efficacy.

    Product
    Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0688-2021·2021-07-28

    69MODE Blue 69 Capsules Recalled for Undeclared Drug Ingredients

    Nuri Trading LLC is recalling 69MODE Blue 69 capsules nationwide because they contain undeclared tadalafil and sildenafil, two FDA-approved drugs, making the product an unapproved drug without established safety or efficacy.

    Product
    69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0654-2021·2021-07-21

    Poseidon Platinum 3500 Capsules Recalled for Undeclared Prescription Drugs

    Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.

    Product
    Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0642-2021·2021-07-07

    Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.

    Product
    Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0641-2021·2021-07-07

    Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.

    Product
    Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
    Category
    Drug
    Distribution
    Distributed nationwide