17,898 recalls, newest first
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved…
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason Labeling: Incorrect or Missing Package Insert
Reason Subpotent Drug: Out of specification for assay
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Chemical Contamination; presence of benzene.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason CGMP Deviations
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the…