A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines.
709 FDA drug recalls with this cause, newest first.
This category covers two things the label never mentions. One is chemical contamination: benzene in sunscreens and hand sanitizers, methanol in sanitizer, lead or other heavy metals in a finished product. The other is a 'supplement' that secretly contains a prescription drug - sildenafil, tadalafil, sibutramine, phenolphthalein - so that it appears to work, at the cost of dangerous interactions the buyer cannot anticipate. A large share of these recalls are Class I, because the hidden ingredient is the whole risk.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Labeling - product contains undeclared ethyl alcohol
Labeling - product contains undeclared ethyl alcohol
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
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