1,122 recalls, newest first
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA…
Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Reason Product mixup: one foreign tablet found in product.
Reason Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Reason Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each…
Reason Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Reason Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Lack of assurance of sterility.
Reason Lack of Assurance of Sterility: Malformed crimped collar seal
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP deviations.
Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Reason CGMP deviation: product outside labeled storage temperature requirements.