Fresh Recalls

Duloxetine Delayed-Release Capsules: recall status

⚠ Recalls found. Duloxetine Delayed-Release Capsules is named in 3 official recalls in our current data:

Brand
Ajanta Pharma

Recalls naming this model

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0514-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0515-2026 · Official record ↗

FDA Class II · Drug · May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Company / brand: Ajanta Pharma recalls

Affected product: Duloxetine Delayed-Release Capsules recall status

Official ID D-0516-2026 · Official record ↗

See all Ajanta Pharma recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.