18,003 recalls, newest first
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with 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: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Product mixup: one foreign tablet found in product.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Lack of assurance of sterility.
Lack of Assurance of Sterility: Malformed crimped collar seal
Subpotent Drug: Out of specification results for low potency was obtained.
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
CGMP deviations.
CGMP deviations.
CGMP deviations.
CGMP deviations.
CGMP deviations.
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.
CGMP deviation: product outside labeled storage temperature requirements.