17,898 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 Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Reason Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Reason Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Reason Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Reason Discoloration: Dotted and yellow spots on tablets
Reason Discoloration: Dotted and yellow spots on tablets
Reason Subpotent drug
Reason Lack of Assurance of Sterility: Complaints of syringe breakage
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…
Reason Failed Release Testing: Out of specification for particulate matter test.
Reason Marketed Without An Approved NDA/ANDA
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…