Home / Recalls / Ajanta Pharma Ltd. / D-0514-2026

D-0514-2026 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: 312,894 packs

Product Description

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 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#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.