Ajanta Pharma recalls
FDA enforcement reports naming Ajanta Pharma Ltd. as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Sep 16, 2026
- Sep 16, 2026Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by:…Drug · Ajanta Pharma USA IncFailed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.Class III
- Jul 1, 2026Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma…Drug · Ajanta Pharma USA IncCGMP DeviationsClass II
- Jun 24, 2026Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA IncDrug · Ajanta Pharma USA IncProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.Class II
- May 13, 2026Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 CapsulesDrug · 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.Class II
- May 13, 2026Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta P…Drug · 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.Class II
- May 13, 2026Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta P…Drug · 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.Class II