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.

276–300 of 547

  • 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-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-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-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
  • 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-0562-2018·2018-02-07

    Unapproved Sildenafil Tablets Recalled by FDA for Lack of Safety Data

    The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0568-2018·2018-02-07

    FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0553-2018·2018-02-07

    Unapproved Indian God Lotion Spray Bottle Recalled by FDA

    A&H Focal Inc. is recalling Indian God Lotion Spray Bottles because the product is an unapproved drug containing diethyl phthalate.

    Product
    Indian God Lotion Spray Bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0470-2018·2018-01-31

    Hard Times For Men capsules recalled for undeclared sildenafil

    The FDA is recalling Hard Times For Men capsules because they contain undeclared sildenafil and were marketed without an approved NDA or ANDA.

    Product
    Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0471-2018·2018-01-31

    BotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine

    BotanicalNow is recalling BodySlim Herbal capsules because FDA analysis found undeclared sibutramine, a substance not approved for use in this product.

    Product
    BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0149-2018·2018-01-10

    FDA Recalls Unapproved Enhanced Vegetal Vigra Capsules Tainted with Sildenafil

    Natures Supplement is recalling Enhanced Vegetal Vigra 200 mg capsules because FDA analysis found the product was tainted with Sildenafil and marketed without an approved NDA/ANDA.

    Product
    Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0122-2018·2017-12-27

    LaBri's Body Health XPLODE Recalled for Unapproved Sibutramine

    EZWeightLossTX LLC is recalling LaBri's Body Health XPLODE capsules because they contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0121-2018·2017-12-27

    FDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination

    EZWeightLossTX LLC is recalling LaBri's Body Health Atomic 60 Capsules because the product was found to contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0105-2018·2017-12-13

    Gadget Island Recalls FIFTY SHADES 6000 Capsules for Undeclared Ingredients

    Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules because they contain undeclared active pharmaceutical ingredients sildenafil, desmethyl carbodenafil, and tadalafil.

    Product
    FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0103-2018·2017-12-13

    Gadget Island Recalls Unapproved Rhino 7 Platinum 5000 Capsules

    Gadget Island, Inc. is recalling Rhino 7 Platinum 5000 capsules because they contain undeclared active pharmaceutical ingredients and were marketed without FDA approval.

    Product
    RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0095-2018·2017-12-06

    Faiza Beauty Cream Recalled for Marketing Without FDA Approval

    New Reliance Trading, Inc. is recalling No.1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0084-2018·2017-11-29

    FDA Recalls Unapproved Faiza Beauty Cream Distributed in New York

    The FDA is recalling No. 1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0058-2018·2017-11-08

    A1 Slim Dietary Supplement Recalled for Undeclared Unapproved Drug Ingredients

    Kiriko, LLC. is recalling A1 Slim dietary supplements because FDA analysis found undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine.

    Product
    A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] Bar-Code A105212014
    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
  • SevereFDA (Drugs)·D-1142-2017·2017-09-20

    Andropharm Sten Z capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 150 bottles of Andropharm Sten Z capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1143-2017·2017-09-20

    Andropharm M1 Alpha capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 1,250 bottles of M1 Alpha capsules sold in Florida because the product was marketed without an approved NDA or ANDA.

    Product
    ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
    Category
    Drug
    Distribution
    1 state