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Ajanta Pharma Ltd.: 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, N

DrugsSource: FDA (drug) · Date: 2026-05-13

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ajanta Pharma Ltd.
Product
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
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within U.S
Recall initiated
2026-04-29
Code info
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Product quantity
312,894 packs
Voluntary mandated
Voluntary: Firm initiated
City
Aurangabad
Country
India
Event id
98785
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