FDAClass II · Drug · Recalled May 13, 2026

Duloxetine Delayed-Release Capsules recall — Ajanta Pharma Ltd.

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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0515-2026
Brand: Ajanta Pharma
Classification: Class II
Units affected: 77,376 packs.
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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

Affected products

Duloxetine Delayed-Release Capsules

Companies & origin

Recalling firm location: Aurangabad, India
Firm address: B-4/5/6 MIDC Industrial Area, Paithan, N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot#: PA07434, Exp. May 2026.
Distribution: Nationwide within U.S
Firm notified the public via: Letter
FDA event ID: 98785
Recall initiated: April 29, 2026
FDA classified: May 4, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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