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.
Fagron Compounding Services
Lack of Assurance of Sterility
Alvogen, Inc
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Direct Rx
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
APO-QUETIAPINE XR
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 c…
PMS-FLUOXETINE 10 mg
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 c…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed Dissolution Specifications.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Ascent Consumer Products Inc.
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc.
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc.
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
RemedyRepack Inc.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
SKY PACKAGING
Failed Impurities/Degradation Specifications