The recalls listed below are active notices associated with Ajanta Pharma Ltd. in the FDA, NHTSA, USDA, and CPSC databases. None of the current recalls are classified as urgent. Check the specific lot numbers, model numbers, or production date codes in each notice carefully — a recall typically covers specific production runs, not everything a manufacturer sells.
A manufacturer appearing in the recall database does not indicate an ongoing safety failure. High-volume companies with large product lines naturally appear more frequently. What matters is whether your specific product — identified by lot number, model number, or date code — is included in a recall notice.
Browse all medication recalls →NoticeMedications
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,
Ajanta Pharma Ltd.
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.
NoticeMedications
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Ajanta Pharma Ltd.
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.
NoticeMedications
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Ajanta Pharma Ltd.
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.