Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
Boehringer Ingelheim Pharmaceuticals, Inc.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a dif…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to cus…
BioMed Laboratories, LLC.
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
ACCORD BIOPHARMA INC
Lack of assurance of Sterility:
Nicotine Pouch
Unauthorized product. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any heal…
Asclemed USA Inc.
Lack of Assurance of Sterility
ACCORD HEALTHCARE, INC.
Subpotent Drug
Asclemed USA Inc.
Lack of Assurance of Sterility
Sodium chloride injection; Sodium chloride Irrigation; (20 mmol/L) Potassium chloride in 5% Dextrose and 0.9% Sodium chloride injection; Lactated Ringer's injection
Packaging. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns…
PMS-Fluconazole 50 mg tablets
Packaging. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns…
ONESOURCE SPECIALTY PHARMA LIMITED
Failed Impurities/Degradation Specifications
Inventia Healthcare Limited
Failed Dissolution Specifications
Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Annora Pharma Private Limited
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.