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.

1–25 of 547

  • CriticalFDA (Drugs)·D-0769-2026·2026-08-19

    Buy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients

    Buy-Herbal is recalling Kian Pee Wan Capsules because they contain undeclared dexamethasone and cyproheptadine. The product was sold to consumers via an eBay third-party seller.

    Product
    Kian Pee Wan Capsules, 30-count bottles
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0396-2026·2026-03-11

    Mojo Max Fusion capsules recalled as Class I over undeclared drug ingredients

    Mojo Max Fusion XXX capsules are being recalled because FDA analysis revealed undeclared sildenafil at 13.1 mg per capsule and tadalafil at 13.8 mg per capsule. The FDA has classified this recall as Class I.

    Product
    Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0388-2026·2026-03-11

    Silintan herbal pills recalled as Class I for undeclared meloxicam

    123Herbals is recalling Silintan 25-count pill bottles because FDA analysis revealed the presence of undeclared meloxicam. The FDA has classified this recall as Class I.

    Product
    SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0397-2026·2026-03-11

    MR. 7 Super capsules recalled as Class I over undeclared sildenafil

    StuffbyNainax is recalling MR. 7 SUPER 700000 capsules because FDA analysis revealed the presence of undeclared sildenafil and tadalafil. The FDA has classified this recall as Class I.

    Product
    MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0344-2026·2026-03-04

    Agebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient

    Agebox is recalling 665 bottles of iKids-Growth Day Formula capsules because they contain undeclared ibutamoren, a drug ingredient not approved for marketing in the U.S.

    Product
    Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0345-2026·2026-03-04

    Children's growth supplement recalled for containing undeclared ibutamoren

    Agebox is recalling iKids-Growth (Night Formula) 60-count bottles because the product was marketed without an approved NDA or ANDA and contains undeclared ibutamoren.

    Product
    Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2026·2025-10-29

    Motion sickness patches recalled for being marketed without approved application

    ibspot is recalling three boxes of Taoscare Motion Sickness Patches because the product was marketed without an approved new drug application.

    Product
    Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0531-2025·2025-07-02

    Testosterone Cypionate Injection Recalled Without Approved Application

    Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.

    Product
    TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0493-2025·2025-06-25

    UMOVY ACIDO HIALURONICO supplement recalled for undeclared prescription drugs

    UMOVY ACIDO HIALURONICO dietary supplement has been recalled because it contains undeclared prescription ingredients Dexamethasone and Diclofenac. The product was marketed without FDA approval.

    Product
    UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2025·2025-06-18

    MALEXTRA Dietary Supplement Recalled for Undeclared Pharmaceutical Ingredients

    MALEXTRA Recharge with Extra dietary supplement is being recalled nationwide because laboratory testing found undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil in the product.

    Product
    MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2025·2025-06-18

    Dietary Supplement Electro Buzz Recalled for Undeclared Active Pharmaceutical Ingredients

    SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

    Product
    ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2025·2025-06-04

    Endurance Boost With Horny Goat Weed Supplement Recalled for Undisclosed Drug Content

    VEPEMVA Nutrition's Endurance Boost with Horny Goat Weed has been recalled because it contains Sildenafil and Propoxyphenylsildenafil, undisclosed active pharmaceutical ingredients. The product was marketed and sold without FDA approval.

    Product
    ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2025·2025-01-29

    FOUZEE SugarLin Herbal Formula Capsules Recalled for Undeclared Prescription Drugs

    Shoppers-Plaza is recalling FOUZEE SugarLin Herbal Formula capsules because FDA testing found undeclared metformin and glyburide. The product was marketed without FDA approval.

    Product
    FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0585-2024·2024-07-10

    RAM IT Horny Goat Weed Dietary Supplement Recalled for Undeclared Sildenafil

    Integrity Products recalls RAM IT Horny Goat Weed dietary supplement capsules nationwide because they contain undeclared sildenafil, a prescription drug not listed on the label.

    Product
    RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0494-2024·2024-05-22

    Dietary Supplement Marketed as Unapproved Drug Without FDA Approval

    Stop Clopez Corp's Schwinnng Herbal Dietary Supplement Capsules were distributed worldwide via Amazon without FDA approval as a new drug. Consumers should discontinue use immediately.

    Product
    Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0470-2024·2024-05-01

    ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil

    ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.

    Product
    ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2024·2024-05-01

    The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients

    The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2024·2024-05-01

    Spanish Fly 22K Capsules Recalled for Undeclared Prescription Drug Ingredients

    Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.

    Product
    Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2024·2024-05-01

    FDA Recalls libigrow RED DRAGON+ Capsules for Undeclared Sildenafil and Tadalafil

    Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.

    Product
    libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2024·2024-03-27

    FDA Recalls Unapproved Tianeptine Elixir Drug Product Nationwide

    Neptune's Fix Tianeptine Elixir, distributed nationwide by Super Chill Products, is recalled because it contains tianeptine, a substance not approved by the FDA for any medical use in the United States. Consumers should not use this product.

    Product
    Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0343-2024·2024-02-28

    Herbal dietary supplement recalled for undeclared drug ingredient

    Sustain Herbal Dietary Supplement is being recalled nationwide for containing undeclared tadalafil, a pharmaceutical ingredient. The product was marketed as a dietary supplement but contains an unapproved drug.

    Product
    Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2024·2024-02-28

    FDA Recalls Neptune's Fix Tianeptine Elixir for Containing Unapproved Drug

    Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.

    Product
    Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2024·2024-02-28

    Drug Recalled for Marketing Unapproved Tianeptine Without FDA Approval

    Neptune's Fix Tianeptine Elixir is recalled nationwide for containing tianeptine, an FDA-unapproved substance. The product was marketed without required FDA approval.

    Product
    Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2024·2024-02-28

    SCHWINNNG Herbal Dietary Supplement Recalled for Undeclared Nortadalafil Content

    SCHWINNNG Herbal Dietary Supplement (Lot #2108, exp. 10/31/2024) is recalled nationwide because it contains undeclared nortadalafil, an active pharmaceutical ingredient used for male sexual enhancement. The FDA classified this as an unapproved drug.

    Product
    SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2024·2024-02-28

    Dietary supplement Arize recalled for undeclared pharmaceutical ingredient

    Arize Herbal Dietary Supplement contains an undeclared ingredient (nortadalafil), a pharmaceutical used in FDA-approved male sexual enhancement medications, making it an unapproved drug.

    Product
    Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
    Category
    Drug
    Distribution
    Distributed nationwide