Ajanta Pharma Recalls
3 recalls on record · May 13, 2026 to May 13, 2026 · Drugs
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Hazard: 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.
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Hazard: 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.
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,
Hazard: 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.