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.
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected…
AvKARE
Failed Content Uniformity Specifications
PMS-Busulfan 6 mg/mL
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…
Fagron Compounding Services
Lack of Assurance of Sterility
PMS-SUMATRIPTAN
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…
Ascend Laboratories, LLC
Superpotent drug
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications:
Green Lumber Holdings, LLC
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Atlantic Management Resources Ltd.
cGMP violations
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a…
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a…
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a…
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a…