Hazard
547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
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
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.
Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Basic Reset Inc. is recalling 339 bottles of Nuovi Firming Masque because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Basic Reset Inc. is recalling Biogenyx CBD Oil because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Basic Reset Inc. is recalling 391 bottles of CBD Reset 2400 because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Fitoterapia USA Inc. is recalling Mero Macho Passion Fruit Vitamin C Liquid Supplement because it was marketed without an approved NDA/ANDA and found to be tainted with Tadalafil.
La Fresh Group is recalling 83,050 packets of Sunnyside Lotion Wipes because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Select Distributions LLC is recalling Aphrodisiac Platinum 40000 because FDA analysis found the product is tainted with sildenafil and was marketed without an approved NDA/ANDA.
Stiff Boy LLC is recalling The Beast because FDA analysis found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.
D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.
McDaniel Life-Line LLC is voluntarily recalling 150 vials of Indian Herb Paste because the product is an unapproved new drug. The recall covers distribution in the US, Italy, Australia, Canada, and Poland.
McDaniel Life-Line LLC is voluntarily recalling Life-Line Catalytic Activated Energy Water because it is an unapproved new drug. The product was distributed in the US and several international countries.
Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.
Golean Detox US is recalling Golean DETOX capsules because FDA analysis found undeclared sibutramine and phenolphthalein, ingredients not approved for marketing in the US.
Epic Products, LLC is recalling Euphoric Premium Male Performance Enhancer capsules because they contain undeclared sildenafil, tadalafil, and oxytetracycline.
Shoreside Enterprises Inc. is recalling Poseidon Xtreme PLATINUM 4500 because FDA analysis found undeclared sildenafil and tadalafil, making it an unapproved drug.
The FDA is recalling 7K capsules distributed by SX Power Co. because they contain undeclared sildenafil and tadalafil, making them unapproved drugs with unestablished safety and efficacy.
The FDA is recalling Rhino 69 Extreme 50000 capsules because they contain undeclared tadalafil, an unapproved drug with unestablished safety and efficacy.
Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.
Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.
Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Grato Holdings, Inc. is recalling Energique Enervimin CNCR Focus dietary supplements because they are unapproved new drugs based on disease claims.
Grato Holdings is recalling Peaceful Mountain Nasal Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Bella All Natural is recalling Bella Capsules because they contain undeclared sibutramine, a withdrawn controlled substance, making them unapproved drugs.
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).