Home / Recalls / Ajanta Pharma Ltd. / D-0516-2026

D-0516-2026 Class II Ongoing

Recalled by Ajanta Pharma Ltd. — Aurangabad

Recall Details

Product Type: Drugs
Report Date: May 13, 2026
Initiation Date: April 29, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 117,168 packs

Product Description

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

Reason for Recall

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.

Distribution Pattern

Nationwide within U.S

Code Information

Lot#: PA10734, Exp. Jun 2026.