359 recalls, newest first
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Reason Discoloration: Dotted and yellow spots on tablets
Reason Discoloration: Dotted and yellow spots on tablets
Reason Failed Release Testing: Out of specification for particulate matter test.
Reason Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Reason Out of specification for assay
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current…
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.