Reported May 13, 2026 · Ongoing
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC…
Ajanta Pharma Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ajanta Pharma Ltd. · B-4/5/6 MIDC Industrial Area · Aurangabad · N/A
Is this the product you have?
Duloxetine Delayed-Release Capsules30 mgRx Onlya) 90 CapsulesNDC 27241-098-09b) 30 capsulesNDC 27241-098-03c) 1000 CapsulesNDC 27241-098-10
- Marketed byAjanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
- Lot codes and dates
Lot#: a) PA10774Exp. May 2026b) PA10794PA12174Exp. Jun 2026c) PA10804Exp. Jun-26
- Amount recalled
- 312,894 packs
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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