Ajanta Pharma Ltd. FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0Class IIApr 29, 2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified	Class IIDrugs	Apr 29, 2026
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0Class IIApr 29, 2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified	Class IIDrugs	Apr 29, 2026
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,Class IIApr 29, 2026CGMP Deviations: Presence of N-nitroso-Duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified	Class IIDrugs	Apr 29, 2026