Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

91 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 16714-759-01 D-0242-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 16714-758-01 D-0241-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 16714-757-01 D-0240-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 16714-756-01 D-0239-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 16714-755-01 D-0238-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-271-30 D-0237-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-270-30 D-0236-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-269-30 D-0235-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-268-30 D-0234-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-267-30 D-0233-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-266-30 D-0232-2025
Class II · Moderate risk

Atomoxetine Capsules

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-265-30 D-0231-2025
Class II · Moderate risk

Carvedilol 25 mg Tablet

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

Terminated Nitrosamine impurity RemedyRepack Inc. D-0217-2025
Class II · Moderate risk

Carvedilol Tablets

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-164-05 D-0216-2025
Class II · Moderate risk

Carvedilol Tablets

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

Ongoing Nitrosamine impurity Glenmark Pharmaceuticals Inc., USA NDC 68462-165-05 D-0215-2025
Class II · Moderate risk

Duloxetine Delayed-Release Capsules USP

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Terminated Nitrosamine impurity The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7043-04 D-0212-2025

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