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.

476–500 of 547

  • CriticalFDA (Drugs)·D-1322-2014·2014-05-21

    REUMOFAN PLUS Tablets Recalled for Undeclared Ingredients and Lack of Approval

    Pain Free By Nature is recalling REUMOFAN PLUS tablets because they were marketed without FDA approval and contain undeclared diclofenac and methocarbamol.

    Product
    REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1320-2014·2014-05-21

    Flawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval

    Flawless Beauty LLC is recalling Vitamin C Injection ampoules marketed without an approved NDA/ANDA. The product is sold over the counter with labeling indicating disease treatment.

    Product
    Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1317-2014·2014-05-21

    Flawless Beauty Recalls Tatiomax Injection Vials Sold Without FDA Approval

    Flawless Beauty LLC is recalling Tatiomax powder for injection vials because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1318-2014·2014-05-21

    FDA Recalls Unapproved Saluta Reduced Glutathione Injection Powder

    Flawless Beauty LLC is recalling Saluta (reduced glutathione) Powder for Injection because it was marketed without an approved NDA/ANDA and is labeled for use as an antidote.

    Product
    Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manuf
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1319-2014·2014-05-21

    Flawless Beauty LLC Recalls Unapproved Injectable Glutathione Solution

    Flawless Beauty LLC is recalling Relumins Advanced Glutathione injectable solution because it was marketed without an approved NDA or ANDA.

    Product
    Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locu
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1321-2014·2014-05-21

    Flawless Beauty Recalls Sterile Water for Injection Sold Without Approval

    Flawless Beauty LLC is recalling Sterile Water for Injection ampoules sold over the counter without an approved NDA or ANDA.

    Product
    Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2014·2014-05-21

    Flawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution

    Flawless Beauty LLC is recalling Laroscorbine Platinium injectable solution because it was marketed without an approved NDA/ANDA and includes drug claims to act as an antidote.

    Product
    Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-S
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1277-2014·2014-05-07

    Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval

    Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/ANDA.

    Product
    Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1248-2014·2014-04-30

    Fossil Fuel Products Recalls RezzRX Capsules for Undeclared Ingredients

    Fossil Fuel Products, LLC is recalling RezzRX capsules because they contain undeclared hydroxylthiohomosildenafil and aminotadalafil.

    Product
    RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1233-2014·2014-04-23

    Slim Expert Softgels Recalled for Undeclared Sibutramine

    B @ B Trade Inc. is recalling Slim Expert softgels because they contain undeclared sibutramine and were marketed without FDA approval.

    Product
    Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1236-2014·2014-04-23

    PHUK Sexual Enhancement Supplement Recalled for Unapproved Active Ingredients

    Haute Health, LLC is recalling PHUK Sexual Enhancement Ultimate Pleasure because it may contain unapproved active ingredients found in FDA-approved erectile dysfunction drugs.

    Product
    PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1235-2014·2014-04-23

    Prolifta Dietary Supplement Recalled for Unapproved Erectile Dysfunction Ingredients

    Haute Health, LLC is recalling Prolifta dietary supplements because they may contain unapproved active ingredients used in erectile dysfunction drugs.

    Product
    Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1220-2014·2014-04-16

    Dr. Ming's Chinese Capsule Recalled for Undeclared Sibutramine and Phenolphthalein

    Slim Beauty USA is recalling Dr. Ming's Chinese Capsule because it contains undeclared sibutramine and phenolphthalein, making it an unapproved new drug.

    Product
    Dr. Ming's Chinese Capsule (Ginger 50 mg, Camellia Sinensis 50 mg, Malus Domestica 50 mg, Propetary Blend 300 mg Cynara Scolymus, Hoodia, Siruline, Chitosan, 60-count bottles, Distributed by Natural Products, Doral, FL 33178.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1222-2014·2014-04-16

    Dream Body Slimming Capsule Recalled for Undeclared Sibutramine

    Slim Beauty USA is recalling Dream Body Slimming Capsules because they contain undeclared sibutramine, an unapproved new drug not currently marketed in the United States.

    Product
    Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1221-2014·2014-04-16

    Slim Beauty USA Recalls Magic Slim Capsules Containing Unapproved Ingredients

    Slim Beauty USA is recalling Magic Slim capsules nationwide because they contain undeclared sibutramine and phenolphthalein, making them unapproved new drugs.

    Product
    Magic Slim capsules (Ling Zhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Nature Substance), 60-count bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1169-2014·2014-03-26

    Clalis capsules recalled for undeclared sildenafil ingredient

    Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.

    Product
    Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1149-2014·2014-03-12

    B-50 Capsules Recalled for Containing Unapproved Steroid Ingredients

    Mira Health Products Ltd. is recalling B-50 capsules because they contain unapproved steroid ingredients, making them unapproved new drugs.

    Product
    B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1150-2014·2014-03-12

    Mira Health Recalls Super-DMZ Rx 2.0 Capsules for Unapproved Steroid Ingredient

    Mira Health Products Ltd. is recalling Super-DMZ Rx 2.0 Capsules because the product contains an unapproved steroid ingredient and was marketed without FDA approval.

    Product
    Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2014·2014-03-12

    Mira Health Recalls Unapproved Metha-Drol Extreme Dietary Supplement

    Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules because the product contains an unapproved steroid ingredient.

    Product
    METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1050-2014·2014-02-05

    FDA Recalls Hydravax Weight Loss Supplement for Undeclared Prescription Drug

    IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution because it contains an undeclared prescription diuretic, Triamterene.

    Product
    Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1046-2014·2014-02-05

    MaXtremeZEN Capsules Recalled for Containing Unapproved Drug Ingredients

    SS Wholesale Inc. is recalling MaXtremeZEN capsules because FDA analysis found undeclared desmethyl carbondenafil and dapoxetine, making the product an unapproved new drug.

    Product
    MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-370-2014·2013-12-25

    Zi Xiu Tang Ultimate Formula Recalled for Undeclared Sibutramine

    Zi Xiu Tang Success, LLC is recalling Ultimate Formula capsules because they contain undeclared sibutramine, an ingredient removed from the market for safety reasons.

    Product
    Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-378-2014·2013-12-25

    PRO POWER MAX Energy Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Fabscout Entertainment is recalling PRO POWER MAX Natural Energy Enhancer capsules because they contain undeclared sildenafil and tadalafil and were marketed without FDA approval.

    Product
    PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-373-2014·2013-12-25

    Purity First B-50 Capsules Recalled for Undeclared Steroids

    Healthy Life Chemistry is recalling B-50 capsules because FDA analysis found undeclared steroids, making the product an unapproved new drug.

    Product
    B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
    Category
    Drug
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-376-2014·2013-12-25

    Evil Root 1200 mg Recalled for Undeclared Sildenafil

    Fabscout Entertainment, Inc. is recalling Evil Root 1200 mg capsules because the product contains undeclared sildenafil and was marketed without FDA approval.

    Product
    Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
    Category
    Drug
    Distribution
    3 states