FreshRecalls

Duloxetine Delayed-Release Capsules: recall status

⚠ Recall found. Duloxetine Delayed-Release Capsules is named in 3 official recalls in our current data. Details and the official notices are below — act on the remedy in the official notice.

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.

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.

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-0516-2026 · Official record ↗

See all Ajanta Pharma recalls →

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 1:09 AM UTC.