Ajanta Pharma USA Inc recalls
7 recalls filed under Ajanta Pharma USA Inc. The most recent was published October 7, 2026.
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Class II · 18 days ago
Ajanta Pharma USA Inc Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle recall: Failed Dissolution Specifications: below specification
Failed Dissolution Specifications: below specification
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Class III · last month
Ajanta Pharma USA Inc Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles recall: Failed impurities/degradation specifications: (OOS) for Organic Impurities
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability…
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Class II · 4 months ago
Ajanta Pharma USA Inc Fenofibrate Capsules, USP 200 mg recall: CGMP Deviations
CGMP Deviations
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Class II · 4 months ago
Ajanta Pharma USA Inc Aripiprazole Tablets USP recall: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 60 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
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…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 20 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
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…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 30 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
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…
About this page
Ajanta Pharma USA Inc appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.