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FDAApril 29, 2026drug

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

ajanta pharmaajanta

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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