The Recall Desk

Hazard

Undeclared Drug recalls

74 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
74
Critical
63
Severe
9
Most recent
2024-05-01

Of the 74 undeclared drug recalls we have scored against our rubric, 63 (85%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (12%) 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 undeclared 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.

1–25 of 74

  • SevereFDA (Drugs)·D-0450-2024·2024-05-01

    FDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil

    Flower Power CBD infused Female Enhancement contains undeclared sildenafil and tadalafil. These prescription drugs were not disclosed to consumers and the product was marketed without FDA approval.

    Product
    Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2024·2024-05-01

    Samurai-X Honey 6800 Recalled for Undeclared Drug Ingredients

    Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.

    Product
    Samurai-X Honey 6800, UPC 2 56891 27553 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1336-2022·2022-07-27

    Dietary supplement found to contain undeclared pharmaceutical drug tadalafil

    Launch Sequence Capsules dietary supplement recalled for containing undeclared tadalafil, an FDA-approved pharmaceutical ingredient. The product was marketed without required drug approval.

    Product
    Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0155-2022·2021-11-17

    NOW Royal Jelly supplements may contain undeclared Metronidazole

    NOW Health Group Inc. is recalling NOW Royal Jelly 1500mg capsules and related private label versions because they may contain Metronidazole, an undeclared pharmaceutical ingredient. The recall affects approximately 88,890 units distributed across the United States and internationally.

    Product
    NOW Royal Jelly 1500mg 60 VCAPS UPC 733739025654 NOW Royal Jelly 1500mg 60 VCAPS (Distributed by Sofico) UPC 733739150523 Lifesource Vitamins 1500mg 60 Veg Caps UPC 610265580430
    Category
    Food
    Distribution
    47 states
  • ModerateFDA (Food)·F-0157-2022·2021-11-17

    NOW Bee Pollen 500mg Capsules Recalled for Metronidazole Contamination

    NOW Health Group Inc. is recalling NOW Bee Pollen 500mg 100 VCAPS (UPC 733739025203) because the product may contain Metronidazole, an antibiotic not listed on the label.

    Product
    NOW Bee Pollen 500mg 100 VCAPS UPC 733739025203
    Category
    Food
    Distribution
    47 states
  • CriticalFDA (Drugs)·D-1080-2020·2020-04-08

    Natural Remedies Active Male Formula Recalled for Undeclared Tadalafil

    FDA is recalling Natural Remedies Active Male 500 mg dietary supplements because they contain undeclared Tadalafil, an FDA-approved drug for erectile dysfunction.

    Product
    Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement Manufactured For: Natural Remedies San Antonio, TX, USA 1(877)543-3501
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1036-2020·2020-03-25

    UP2 Libido Supplement Recalled for Undeclared Sildenafil

    Med Man Distribution is recalling UP2 dietary supplements because FDA analysis found undeclared sildenafil, a prescription drug, in the product.

    Product
    UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0655-2020·2020-01-22

    FDA Recalls Unapproved Stallion Platinum 30000 Capsules Containing Tadalafil

    Motto International Corp is recalling Stallion Platinum 30000 Capsules because FDA analysis found the unapproved product contains tadalafil.

    Product
    Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0351-2020·2019-11-13

    Green Lumber Natural Fuel For Men capsules recalled for undeclared Tadalafil

    Green Lumber Holdings is recalling Natural Fuel For Men capsules because FDA analysis found undeclared Tadalafil, an approved drug for erectile dysfunction.

    Product
    Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1206-2019·2019-04-24

    Herbal Coffee Recalled for Undeclared Erectile Dysfunction Drugs

    The FDA is recalling Kopi Jantan Tradisional Natural Herbs Coffee because it contains undeclared sildenafil and tadalafil, unapproved drugs for erectile dysfunction.

    Product
    Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1135-2019·2019-04-17

    FDA Recalls Leopard Miracle Honey Containing Undeclared Sildenafil

    USA LESS Inc. is recalling Leopard Miracle Honey because it contains undeclared sildenafil, an unapproved drug for erectile dysfunction.

    Product
    LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0500-2019·2019-02-13

    Nature's Rx Silver Bullet 10x Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Nature's Rx is recalling Silver Bullet 10x Capsules sold on eBay because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0388-2019·2019-01-30

    5K Premium Enhancement capsules recalled for undeclared sildenafil and tadalafil

    Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0288-2019·2018-11-21

    Euphoric Male Performance Enhancer Recalled for Undeclared Prescription Drugs

    Epic Products, LLC is recalling Euphoric Premium Male Performance Enhancer capsules because they contain undeclared sildenafil, tadalafil, and oxytetracycline.

    Product
    Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2019·2018-11-21

    Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine

    Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0625-2018·2018-04-04

    Red Zone Xtreme 3000 Capsules Recalled for Undeclared Tadalafil

    The FDA is recalling Red Zone Xtreme 3000 Capsules because FDA analysis found the product contains undeclared Tadalafil, an approved drug for erectile dysfunction.

    Product
    Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0126-2018·2017-12-27

    FDA Recalls Natural Herbal Coffee AMPT for Undeclared Sildenafil and Tadalafil

    The FDA is recalling Natural Herbal Coffee AMPT because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.

    Product
    NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0106-2018·2017-12-13

    Grande X 5800 Capsules Recalled for Undeclared Prescription Ingredients

    Gadget Island, Inc. is recalling Grande X 5800 capsules because they contain undeclared prescription drugs sildenafil, desmethyl carbodenafil, and tadalafil.

    Product
    grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distri
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0032-2018·2017-11-01

    Vitility Recalls MAN OF STEEL Capsules Containing Undeclared Sildenafil

    Vitility is recalling MAN OF STEEL capsules because FDA analysis found they contain undeclared sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1144-2017·2017-09-20

    FDA Recalls New Kopi Jantan Coffee for Undeclared Ingredients

    Bestherbs Coffee LLC is recalling New Kopi Jantan coffee packets because they contain undeclared desmethyl carbodenafil and milk.

    Product
    New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1117-2017·2017-08-30

    CaverFlo Natural Herbal Coffee Recalled for Undeclared Sildenafil and Tadalafil

    The FDA is recalling CaverFlo Natural Herbal Coffee because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.

    Product
    CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0961-2017·2017-07-19

    UPROAR Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling UPROAR male enhancement capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0970-2017·2017-07-19

    FDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs

    Organic Herbal Supply is recalling ZRECT for Women herbal capsules because FDA testing found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0966-2017·2017-07-19

    Tornado Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling Tornado Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

    Product
    TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0967-2017·2017-07-19

    FDA Recalls ZDaily Testosterone Supplement for Undeclared Prescription Drugs

    Organic Herbal Supply is recalling ZDaily Testosterone and Libido Booster capsules because FDA analysis found undeclared prescription drugs, including tadalafil, sildenafil, and flibanserin.

    Product
    ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062
    Category
    Drug
    Distribution
    Distributed nationwide