18,003 recalls, newest first
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Failed Stability Specifications: Out of specification for blend uniformity.
Failed Dissolution Specifications: results slightly under spec at at 9-months.
CGMP Deviations: potential presence of Burkholderia cepacia complex
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
cGMP Deviations: Products were stored outside the drug label specifications.
cGMP Deviations: Products were stored outside the drug label specifications.
cGMP Deviations: Products were stored outside the drug label specifications.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Failed Dissolution Specifications: Out of specification for dissolution.
Labeling: Incorrect or Missing Package Insert
Subpotent Drug: Out of specification for assay
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Chemical Contamination; presence of benzene.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility