17,898 recalls, newest first
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Failed dissolution specifications: below specification results at stability 12-month
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled…
Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Reason Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Reason Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled…
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Reason Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Reason Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for…
Reason Failed dissolution specifications - results obtained were below spec average.
Reason CGMP Deviations