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.

376–400 of 547

  • ModerateFDA (Food)·F-1164-2016·2016-05-11

    Iowa Select Herbs Cranberry Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 7.5 fl. oz. bottles of Cranberry because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Cranberry, www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1204-2016·2016-05-11

    Iowa Select Herbs Recalls Papaya Leaf Products for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Papaya Leaf products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Papaya Leaf (Carica papaya), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 16 fl. Oz. (d) 32 fl. Oz. (e) 32 & 16 fl. Oz. (f) 128 fl. Oz. (g) 164 fl. Oz. (h) unknown size, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1166-2016·2016-05-11

    Iowa Select Herbs Recalls Cyperus Leaf for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 1-gallon bottles of Alcohol-Free Cyperus Leaf because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Cyperus Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1147-2016·2016-05-11

    Iowa Select Herbs Recalls Bitter Melon Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling Bitter Melon dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Bitter Melon (Momordica charantia, www.iowaselectherbs.com, 32 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1163-2016·2016-05-11

    Iowa Select Herbs Recalls Cold Be Gone for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Cold Be Gone products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1186-2016·2016-05-11

    Iowa Select Herbs Recalls Jerusalem Artichoke for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 4 fl. oz. bottles of Jerusalem Artichoke because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Jerusalem Artichoke www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1230-2016·2016-05-11

    Iowa Select Herbs Recalls White Willow Bark for Misbranding

    Iowa Select Herbs LLC is recalling White Willow Bark products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, White Willow Bark, www.iowaselectherbs.com, (a) 16 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1162-2016·2016-05-11

    Iowa Select Herbs Recalls Citrus Peel Product for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Citrus Peel (Uncaria tomentosa) because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC,Citrus Peel (Uncaria tomentosa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1143-2016·2016-05-11

    Iowa Select Herbs Recalls Atractylodes for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Atractylodes (Atractylodes macrocephala) under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC,Atractylodes (Atractylodes macrocephala), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0772-2016·2016-03-16

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    Tf Supplements is recalling Rhino 7 Platinum 3000 because it contains undeclared desmethyl carbondenafil and dapoxetine and was marketed without an approved NDA or ANDA.

    Product
    Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0771-2016·2016-03-16

    Tf Supplements Recalls Rhino 7 3000 Due to Undeclared Ingredients

    Tf Supplements is recalling Rhino 7 3000 bottles because they contain undeclared desmethyl carbondenafil and dapoxetine and were marketed without an approved NDA or ANDA.

    Product
    RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0673-2016·2016-02-24

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    FDA recalls Rhino 7 Platinum 3000 because it contains undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.

    Product
    Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0670-2016·2016-02-24

    Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients

    MSNV, Inc dba National Video Supply is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients.

    Product
    Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0672-2016·2016-02-24

    Rhino 7 3000 Recalled for Undeclared Active Pharmaceutical Ingredients

    Premiere Sales Group is recalling Rhino 7 3000 bottles because they contain undeclared active pharmaceutical ingredients, desmethyl carbondenafil and dapoxetine.

    Product
    Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0667-2016·2016-02-24

    APEXXX tablets recalled for containing unapproved sildenafil

    Nuway Distributors is recalling APEXXX tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0671-2016·2016-02-24

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    MSNV, Inc dba National Video Supply is recalling Rhino 7 Platinum 3000 single blister packs because they contain undeclared active pharmaceutical ingredients.

    Product
    Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0665-2016·2016-02-24

    Bonita Pharmaceuticals Recalls Menthocin Patch with Lidocaine-Strong

    Bonita Pharmaceuticals is recalling Menthocin Patch with Lidocaine-Strong because it was marketed without an approved NDA or ANDA.

    Product
    Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0392-2016·2015-12-09

    Geritrex Recalls Unapproved Hydrocortisone Suppositories Nationwide

    Geritrex Corp is recalling GRx HiCort 25 suppositories because the FDA determined they are unapproved new drugs and misbranded.

    Product
    GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0393-2016·2015-12-09

    Geritrex Recalls Unapproved Polyethylene Glycol 3350 Powder Jars

    Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0390-2016·2015-12-09

    Geritrex Recalls Unapproved Carbo-O-Philic 40 Cream Tubes Nationwide

    Geritrex Corporation is recalling Carbo-O-Philic 40 Cream tubes because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0391-2016·2015-12-09

    Geritrex Recalls Unapproved Carbo-O-Philic 40 Gel Topical Urea Product

    Geritrex Corp is recalling Carbo-O-Philic 40 Gel because the FDA determined it is an unapproved new drug and misbranded.

    Product
    Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0297-2016·2015-11-25

    KABOOM Action Strips Recalled for Undeclared Sulfoaildenafil

    Blue Square Market, Inc. is recalling KABOOM action strips because they contain undeclared sulfoaildenafil and were marketed without an approved NDA or ANDA.

    Product
    KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0229-2016·2015-11-18

    Miracle Rock 48 capsules recalled for containing undeclared thiosildenafil

    The One Minute Miracle Inc. is recalling Miracle Rock 48 capsules because they contain undeclared thiosildenafil, an unapproved drug analogue.

    Product
    MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0230-2016·2015-11-18

    Miracle Diet 30 Recalled for Undeclared Phenolphthalein

    The One Minute Miracle Inc. is recalling Miracle Diet 30 capsules because they contain undeclared phenolphthalein, an unapproved drug ingredient.

    Product
    MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1330-2015·2015-08-26

    PYROLA Advanced Joint Formula Recalled for Undeclared Prescription Drugs

    GC Natural Nutrition is recalling PYROLA Advanced Joint Formula capsules because they contain undeclared prescription and over-the-counter drugs.

    Product
    PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
    Category
    Drug
    Distribution
    Distributed nationwide