FDAHealthApril 29, 2026

Ajanta Pharma Ltd. — 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.

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 29, 2026

Nationwide within U.S

What's affected?

Product: 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.
Brand: DULOXETINE
UPC: 0327241164309
Lot code: PA10734

Additional details

Lot#: PA10734, Exp. Jun 2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 117,168 packs.

View original FDA notice →

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