17,898 recalls, newest first
Reason Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
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
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specification.
Reason Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Reason Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of…
Reason Lack of Sterility Assurance: Aseptic process simulation failure.
Reason Failed Dissolution Specifications
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Reason Subpotent Drug and Failed Impurities/Degradation Specifications
Reason Labeling: Label Mix-up
Reason Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Reason Failed Impurities/Degradation Specifications
Reason Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Reason Failed Dissolution Specifications
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Presence of Foreign Tablets/Capsules
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.