Data Composite

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.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-29

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Ascent Consumer Products Inc.

US Class I Ongoing · initiated 2025-01-28

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Ascent Consumer Products Inc.

US Class I Ongoing · initiated 2025-01-28

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Ascent Consumer Products Inc.

US Class I Ongoing · initiated 2025-01-28

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

RemedyRepack Inc.

US Class II Terminated · initiated 2025-01-24

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

SKY PACKAGING

US Class II Ongoing · initiated 2025-01-24

Failed Impurities/Degradation Specifications

SKY PACKAGING

US Class II Ongoing · initiated 2025-01-24

Failed Impurities/Degradation Specifications

FDC Limited

US Class II Ongoing · initiated 2025-01-23

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

US Class II Ongoing · initiated 2025-01-22

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Glenmark Pharmaceuticals Inc., USA

US Class II Ongoing · initiated 2025-01-22

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

AvKARE

US Class II Ongoing · initiated 2025-01-21

Out of Specification for Dissolution

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

US Class II Ongoing · initiated 2025-01-21

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impu…

Provepharm Inc.

US Class I Ongoing · initiated 2025-01-21

Presence of Particulate Matter.