Ajanta Pharma Ltd.: Duloxetine Delayed-release Capsules, 30 Mg

Duloxetine Recall Summary Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules, 30 mg, distributed nationwide, because testing found higher-than-acceptable levels of an impurity called N-nitroso-Duloxetine in some batches. The recall affects three package sizes (30, 90, and 1000 capsules) that were distributed across all U.S. states and Washington, D.C. This is a Class II recall, meaning there is a potential health risk, though the company has not specified what that risk may be.

Recalling firm

Ajanta Pharma Ltd.

Product

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

Reason

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.

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-29

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within U.S

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/1c6bd63e-388e-480b-8628-4fb51b1b741d