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.
SKY PACKAGING
Failed Impurities/Degradation Specifications
FDC Limited
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.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
AvKARE
Out of Specification for Dissolution
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…
Provepharm Inc.
Presence of Particulate Matter.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…
Create Compounding Pharmacy - Semaglutide + Pyridoxine
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 W.S. Badger Company, Inc.
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
McKesson
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Appco Pharma LLC
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
AG-Escitalopram
Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…
Teva Pharmaceuticals USA, Inc
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Johnson, S C and Son, Inc
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Amerisource Health Services LLC
Presence of Foreign Tablets/Capsules
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Superpotent; sodium benzoate preservative
JAMP - ESCITALOPRAM 20mg
Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…
QUETIAPINE XR
Product quality. Verify if your product is affected.Contact the recalling firm if you have any questions about the recall.Report any health product related side…
Rising Pharma Holding, Inc.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Rising Pharma Holding, Inc.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.