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.

526–547 of 547

  • SevereFDA (Drugs)·D-327-2013·2013-05-22

    Evol Nutrition Recalls Mojo Nights Capsules for Unapproved Ingredients

    Evol Nutrition is recalling Mojo Nights capsules because they contain unapproved ingredients used to treat erectile dysfunction.

    Product
    Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2013·2013-05-22

    FDA Recalls Libigrow Capsules for Undeclared Active Ingredients

    Performance Plus Marketing, Inc. is recalling Libigrow capsules marketed without FDA approval. The product may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-337-2013·2013-05-22

    Mojo nights SUPREME Capsules Recalled for Undeclared Active Ingredients

    Performance Plus Marketing, Inc. is recalling Mojo nights SUPREME Capsules because the product was marketed without an approved NDA/ANDA and may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-267-2013·2013-05-01

    Dietary Supplement Recalled for Undeclared Drug Ingredients

    Brower Enterprises Inc. is recalling WOW Health Enterprises Dietary Supplement because it contains undeclared drug ingredients, making it an unapproved drug.

    Product
    WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-266-2013·2013-04-24

    FDA Recalls Blue Male Enhancement Pill for Unapproved Ingredient

    The Menz Club is recalling Blue Male Enhancement Pill because it contains sulfoaildenafil, an unapproved analogue of sildenafil.

    Product
    Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-231-2013·2013-04-10

    FDA Recalls Unapproved Nootropa Cognitive Enhancement Supplement

    Palmer Natural Products is recalling Nootropa Cognitive Enhancement Supplement because it was marketed without an approved NDA/ANDA.

    Product
    NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Manufactured & Packaged in the USA for NOOTROPA.COM. DEVELOPED BY: Digital Superfuture Limited Arntel Building 9B 148 Des Voeux Rd. Hong Kong.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-233-2013·2013-04-10

    Unapproved Piracetam and Choline Capsules Recalled by FDA

    Palmer Natural Products is recalling unapproved Piracetam and Choline capsules marketed without FDA approval.

    Product
    Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826 ,
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-230-2013·2013-04-10

    Unapproved Aniracetam and Choline Capsules Recalled by FDA

    Palmer Natural Products is recalling Aniracetam & Choline capsules because they were marketed without an approved NDA or ANDA.

    Product
    Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-234-2013·2013-04-10

    FDA Recalls Unapproved Brain Defogger Capsules Sold Online

    Palmer Natural Products is recalling Brain Defogger capsules because they were marketed without FDA approval. The product was sold in Florida, Idaho, California, and Hong Kong.

    Product
    Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. .
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-235-2013·2013-04-10

    FDA Recalls Unapproved Piracetam and Choline Capsules Sold Online

    Palmer Natural Products is recalling 723 bottles of unapproved Piracetam and Choline capsules sold online and in four states.

    Product
    BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC, Orlando, FL 32826
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-236-2013·2013-04-10

    Palmer Natural Products Recalls Unapproved Oxiracetam and Choline Capsules

    Palmer Natural Products is recalling Oxiracetam & Choline capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-232-2013·2013-04-10

    Unapproved Aniracetam and Choline Capsules Recalled by FDA

    Palmer Natural Products is recalling 250 bottles of Aniracetam and Choline capsules because they were marketed without an approved NDA or ANDA.

    Product
    Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-194-2013·2013-03-20

    A B Nutrition Recalls Unapproved Piracetam Dietary Supplement

    A B Nutrition, Inc. is recalling 2,980 bottles of Piracetam dietary supplement because it is an unapproved new drug marketed without an approved NDA or ANDA.

    Product
    PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-195-2013·2013-03-20

    A B Nutrition Recalls Unapproved Piracetam Powder Dietary Supplement

    A B Nutrition, Inc. is recalling 509 bottles of Piracetam Powder marketed as a dietary supplement because it is an unapproved new drug.

    Product
    PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-196-2013·2013-03-20

    A B Nutrition Recalls Unapproved Aniracetam Dietary Supplement

    A B Nutrition, Inc. is recalling 912 bottles of Aniracetam dietary supplement because it is an unapproved new drug marketed without an approved NDA or ANDA.

    Product
    ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-148-2013·2013-02-13

    Globe All Wellness Recalls Slim Xtreme Capsules Containing Unapproved Sibutramine

    Globe All Wellness is recalling Slim Xtreme Herbal Slimming Capsules because testing revealed the presence of sibutramine, an unapproved and withdrawn drug.

    Product
    SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-063-2013·2012-12-05

    Samantha Lynn Recalls Reumofan Plus Tablets for Undeclared Ingredients

    Samantha Lynn, Inc. is recalling Reumofan Plus Tablets because they contain undeclared drug ingredients, making them unapproved drugs.

    Product
    Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-038-2013·2012-11-07

    FDA Recalls Unapproved X-Rock 3 Day Pill For Men

    Coral Rock Man, Inc. is recalling X-Rock 3 Day Pill For Men because the product was marketed without an approved NDA/ANDA and tested positive for Sildenafil and analogs.

    Product
    X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, F
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-009-2013·2012-10-24

    Earthborn Products Recalls Colloidal Silver Supplement for Lack of FDA Approval

    Earthborn Products is recalling 161 gallons of colloidal silver supplements because the FDA determined the product is misbranded and not generally recognized as safe and effective.

    Product
    Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1657-2012·2012-08-29

    FDA Recalls V Maxx Rx Male Enhancement Product for Unapproved Drug Content

    The Menz Club, LLC is recalling V Maxx Rx because FDA testing found it contains an unapproved drug analogue.

    Product
    V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone:
    Category
    Drug
    Distribution
    Distributed nationwide