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.
Dermamedics, L.L.C. is recalling Calm and Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.
Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.
Thorne Research is recalling Captomer-250 capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them unapproved new drugs.
Thorne Research is recalling Captomer capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them unapproved new drugs.
MyNicNaxs, Inc. is recalling Super Fat Burning Bomb Capsules because they contain undeclared active pharmaceutical ingredients, phenolphthalein and N-desmethylsibutramine.
MyNicNaxs, Inc. is recalling Meizi Evolution Soft Gel Capsules because the product was marketed without an approved NDA/ANDA and contains undeclared active pharmaceutical ingredients.
MyNicNaxs, Inc. is recalling Magic Slim capsules because they contain undeclared active pharmaceutical ingredients and were marketed without an approved NDA or ANDA.
MyNicNaxs, Inc. is recalling REDUCE WEIGHT FRUTA PLANTA Capsules because they contain undeclared phenolphthalein and were marketed without FDA approval.
Vitality Research Labs is recalling vitaliKOR capsules because FDA sampling found undeclared vardenafil and tadalafil. The product was marketed without an approved NDA or ANDA.
MyNicNaxs, Inc. is recalling Jianfeijindan Activity Girl Capsules because they contain an undeclared sibutramine analog and were marketed without FDA approval.
MyNicKnaxs is recalling weight reduction pills marketed without FDA approval because they contain undeclared phenolphthalein.
Pure Edge Nutrition is recalling Bella Vi INSANE AMP'D dietary supplements because they contain undeclared sibutramine and phenolphthalein.
MyNicNaxs, Inc. is recalling Fruta BIO 400 mg capsules because they contain undeclared sibutramine and phenolphthalein.
MyNicNaxs, Inc. is recalling Slim Xtreme Weight loss capsules because they contain undeclared active pharmaceutical ingredients, including sibutramine, and were marketed without FDA approval.
MyNicNaxs, Inc. is recalling SlimEasy Herbs Capsules because they contain undeclared sibutramine and N-desmethylsibutramine and were marketed without an approved NDA/ANDA.
Pure Edge Nutrition is recalling Bella Vi BTrim MAX dietary supplements because they contain undeclared sibutramine and phenolphthalein and were marketed without FDA approval.
Herbal Give Care Llc is recalling Esbelder Fem Mezcla con L-Carnitina because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
Schindele Enterprises is recalling XZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
Schindele Enterprises is recalling ExtenZe 600 mg tablets because they contain undeclared sildenafil or tadalafil, which were marketed without an approved NDA or ANDA.
Human Science Foundation is recalling PRO ArthMax tablets because FDA analysis found unapproved prescription drugs in the product.
Schindele Enterprises is recalling Magic For Men dietary supplements because they contain undeclared sildenafil and tadalafil without FDA approval.
Tendex is recalling Naturect Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.
Schindele Enterprises is recalling MiracleZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
Independent Nutrition Center is recalling Red Yeast Rice High Potency Dietary Supplement because it contains excessive levels of lovastatin, an FDA-approved drug.
Tendex is recalling P-Boost Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.