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.
Padagis US LLC
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Polyflex 25 g/vial powder for suspension
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
The Harvard Drug Group LLC
Subpotent Drug
Lancora 5 mg tablet
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
Par Health USA, LLC
Crystallization; identified as Buprenorphine free base
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…