17,898 recalls, newest first
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason Failed Impurities/Degradations Specifications
Reason CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Reason Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability…
Reason Presence of Particulate matter: Particulate matter identified as glass.
Reason Lack of Assurance of Sterility
Reason Subpotent Drug
Reason Defective Container; packets were found to be either empty or partially full.
Reason Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Reason Lack of Assurance of Sterility
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Failed Impurities/Degradation Specifications
Reason Presence of a Foreign Substance; black particles observed in liquid
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
Reason Presence of Particulate Matter.
Reason Failed Dissolution Specifications