FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

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-0516-2026
Brand
Ajanta Pharma
Classification
Class II
Units affected
117,168 packs
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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.

Affected products

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#: PA10734, Exp. Jun 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 23, 2026 at 11:04 PM UTC.

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