Duloxetine Delayed-Release Capsules recalled over manufacturing violations

Recall date

April 29, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ…

Recall number

D-0515-2026

FDA classification

Class II

Brand / firm

Ajanta Pharma Ltd.

Sold / distributed

Nationwide within U.S

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03