The Recall Desk

Hazard

Sildenafil recalls

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

What the numbers show

Total
75
Critical
33
Severe
42
Most recent
2026-04-15

Of the 75 sildenafil recalls we have scored against our rubric, 33 (44%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 42 (56%) 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 sildenafil 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 75

  • SevereFDA (Drugs)·D-0366-2021·2021-05-12

    Thumbs Up 7 Red 70K Recalled for Unapproved Sildenafil and Tadalafil

    Antoto-K is recalling Thumbs Up 7 Red 70K because FDA analysis found unapproved sildenafil and tadalafil. The product was marketed without an approved NDA or ANDA.

    Product
    Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2021·2021-05-05

    Namoo Enterprise Recalls PremierZen Black 5000 Capsules for Unapproved Ingredients

    Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.

    Product
    PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (Drugs)·D-1037-2020·2020-03-25

    Bow and Arrow Libido Supplement Recalled for Undeclared Sildenafil

    Med Man Distribution is recalling Bow & Arrow dietary supplements because they contain undeclared sildenafil, a prescription drug ingredient not listed on the label.

    Product
    Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0558-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.

    Product
    LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0563-2018·2018-02-07

    FDA Recalls Unapproved Zhonghua Niubian Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0566-2018·2018-02-07

    Unapproved herbal capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling HU HU SHENG WEI capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0565-2018·2018-02-07

    FDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil

    A&H Focal Inc. is recalling MAX MAN capsules sold in New York and New Jersey because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0560-2018·2018-02-07

    FDA Recalls Unapproved Clalis Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Clalis capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0552-2018·2018-02-07

    FDA Recalls Unapproved Black Ant Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0572-2018·2018-02-07

    FDA Recalls Unapproved Tiger King Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Tiger King tablets because they contain sildenafil, an unapproved drug for erectile dysfunction, and lack FDA approval.

    Product
    Tiger King tablets, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0567-2018·2018-02-07

    Unapproved Yanshijiaonang Capsules Containing Sildenafil Recalled by FDA

    A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0564-2018·2018-02-07

    STREE OVERLORD capsules recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling STREE OVERLORD capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0557-2018·2018-02-07

    FDA Recalls Unapproved Hard Ten Days Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Hard Ten Days capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0570-2018·2018-02-07

    Unapproved Sildenafil Supplements Recalled by FDA for Lack of Safety Data

    A&H Focal Inc. is recalling LIEN CHAN FOR SEVEN DAYS capsules because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0555-2018·2018-02-07

    Germany Black Gold tablets recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling Germany Black Gold tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0561-2018·2018-02-07

    Unapproved Ye Lang Shen capsules containing sildenafil recalled by FDA

    A&H Focal Inc. is recalling Ye Lang Shen capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0556-2018·2018-02-07

    Germany Niubian tablets recalled for containing unapproved sildenafil

    A&H Focal Inc. is recalling Germany Niubian tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0571-2018·2018-02-07

    FDA Recalls MACA Gold Tablets Containing Unapproved Sildenafil

    A&H Focal Inc. is recalling MACA gold tablets sold in New York and New Jersey because they contain sildenafil, an unapproved drug.

    Product
    MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0569-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • 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