United StatesAjanta Pharma Ltd. is recalling Duloxetine delayed‑release capsules (20 mg, 30 mg, 60 mg) marketed by Ajanta Pharma USA Inc., made in India — notable package/identifier examples include 30 mg: 90 ct NDC 27241‑098‑09 (Lot PA10774, exp May 2026), 30 ct NDC 27241‑098‑03 (Lot PA10794/PA12174, exp Jun 2026), and others as listed. The recall is due to CGMP deviations: detection of N‑nitroso‑Duloxetine impurity above the FDA recommended limit (0.83 ppm) at the 12‑month and 18‑month stability intervals.
What's being recalled
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
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Recalling firm: Ajanta Pharma Ltd., Aurangabad, India.
How to identify it
Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. Lot#: PA07434, Exp. May 2026. Lot#: PA10734, Exp. Jun 2026.
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)