FreshRecalls

Ajanta Pharma recalls

3 recent recalls on record for Ajanta Pharma in CPSC, NHTSA, and FDA data as of July 24, 2026 at 1:09 AM UTC.

Models with recalls

Duloxetine Delayed-Release Capsules (3)

All Ajanta Pharma recalls

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.

Official ID D-0516-2026 · 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.

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.

Official ID D-0514-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked July 24, 2026 at 1:09 AM UTC.