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.

501–525 of 547

  • CriticalFDA (Drugs)·D-377-2014·2013-12-25

    Dietary Supplement Recalled for Undeclared Sildenafil and Lack of FDA Approval

    Fabscout Entertainment is recalling 72HP Maximum Potency Male Sexual Enhancement because it contains undeclared sildenafil and was marketed without FDA approval.

    Product
    72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-371-2014·2013-12-25

    Quick Thin capsules recalled for containing unapproved drugs

    Bethel Nutritional Consulting is recalling Quick Thin capsules because FDA analysis detected unapproved drugs sibutramine and phenolphthalein.

    Product
    Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-374-2014·2013-12-25

    Purity First Recalls Multi-Mineral Capsules for Undeclared Steroids

    Healthy Life Chemistry is recalling multi-mineral capsules because they contain undeclared steroid-like substances, making them unapproved new drugs.

    Product
    Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-345-2014·2013-12-18

    Volcano Male Enhancement Capsules Recalled for Undeclared Pharmaceutical Ingredients

    Myson Corporation is recalling Volcano Male Enhancement capsules because they contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.

    Product
    Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordycep
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-344-2014·2013-12-18

    Volcano Male Enhancement Liquid Recalled for Undeclared Pharmaceutical Ingredients

    Myson Corporation is recalling Volcano Male Enhancement Liquid because it contains undeclared active pharmaceutical ingredients, making it an unapproved new drug.

    Product
    Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-015-2014·2013-11-27

    Affirm XL Nutritional Supplement Recalled for Unapproved Sildenafil Analogue

    Affirm XL is recalling its nutritional supplement because FDA analysis found it contains sulfoaildenafil, an unapproved analogue of sildenafil.

    Product
    Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-929-2013·2013-09-11

    FDA Recalls SexVoltz Herbal Supplement Containing Unapproved Tadalafil

    Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.

    Product
    SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-930-2013·2013-09-11

    Velextra Herbal Supplement Recalled for Containing Unapproved Tadalafil

    Beamonstar Products is recalling Velextra All-Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.

    Product
    Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-921-2013·2013-09-04

    Bethel 30 capsules recalled for undeclared active ingredients

    Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.

    Product
    Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-837-2013·2013-08-14

    Reumofan Plus tablets recalled for undeclared active pharmaceutical ingredients

    Reumofan Plus tablets are being recalled because they were marketed without an approved NDA/ANDA and may contain undeclared active ingredients.

    Product
    Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-833-2013·2013-08-14

    Lightning ROD capsules recalled for undeclared sildenafil analogue

    Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, an unapproved new drug.

    Product
    Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-834-2013·2013-08-14

    Lightning ROD capsules recalled for undeclared sildenafil analogue

    Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, making the product an unapproved new drug.

    Product
    Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-828-2013·2013-08-07

    Green Planet Night Bullet Capsules Recalled for Unapproved Active Ingredients

    Green Planet Inc is recalling Night Bullet Capsules because they contain unapproved active ingredients for erectile dysfunction.

    Product
    Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-622-2013·2013-07-03

    INK-EEZE Tattoo Numbing Spray Recalled for Lack of FDA Approval

    Indelicare LLC is recalling INK-EEZE Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-621-2013·2013-07-03

    FDA Recalls Ink-Eeze Tattoo Numbing Spray for Lack of Approval

    Indelicare LLC is recalling Ink-Eeze Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-600-2013·2013-06-19

    Olaax MAXILOSS Weight Advanced Recalled for Containing Unapproved Sibutramine

    Olaax International is recalling MAXILOSS Weight Advanced capsules because they contain sibutramine, an unapproved drug removed from the U.S. market for safety reasons.

    Product
    MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-325-2013·2013-05-22

    FDA Recalls Unapproved ROCK-IT MAN Male Sexual Stimulant Capsules

    Consumer Concepts is recalling ROCK-IT MAN capsules because FDA analysis found they contain an unapproved sildenafil analogue.

    Product
    ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-334-2013·2013-05-22

    FDA Recalls Blue Diamond Pill for Undeclared Sildenafil and Tadalafil

    Performance Plus Marketing, Inc. is recalling Blue Diamond Pill male sexual enhancement products because they may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-336-2013·2013-05-22

    FDA Recalls Mojo Nights Capsules for Unapproved Active Ingredients

    Performance Plus Marketing is recalling Mojo Nights Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

    Product
    Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-338-2013·2013-05-22

    Casanova Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Performance Plus Marketing is recalling Casanova Capsules because they may contain undeclared sildenafil and tadalafil, making them unapproved drugs.

    Product
    CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-328-2013·2013-05-22

    Evol Nutrition Recalls Mojo Nights for Her Due to Unapproved Ingredients

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

    Product
    Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-335-2013·2013-05-22

    BLUE Diamond Platinum Capsules Recalled for Undeclared Active Ingredients

    Performance Plus Marketing is recalling BLUE Diamond Platinum Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

    Product
    BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-326-2013·2013-05-22

    Unapproved Male Enhancement Supplements Containing Tadalafil Recalled Nationwide

    InSo-Independent Contractor for West Coast Nutritionals, LTD is recalling three unapproved male enhancement products found to contain undeclared tadalafil.

    Product
    a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is p
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-333-2013·2013-05-22

    FDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients

    The FDA is recalling Libigrow XXXTREME Capsules because they were marketed without approval and may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2013·2013-05-22

    Super Power capsules recalled for containing unapproved sildenafil

    D& S Herbals, LLC is recalling Super Power capsules because they contain sildenafil, an unapproved drug ingredient.

    Product
    Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
    Category
    Drug
    Distribution
    Distributed nationwide