FDAClass II · Drug · Recalled June 10, 2026

Duloxetine DR Capsules recall — Asclemed USA Inc.

Hazard: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0555-2026
Brand: Asclemed USA
Classification: Class II
Units affected: 50 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Affected products

Duloxetine DR Capsules

Companies & origin

Recalling firm location: Torrance, CA, United States
Firm address: 379 Van Ness Ave Ste 1403, 90501-7211

Identifying details (verbatim from the notice)

Product codes / lots: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Distribution: US Nationwide.
Firm notified the public via: Letter
FDA event ID: 99019
Recall initiated: May 14, 2026
FDA classified: June 2, 2026
FDA report date: June 10, 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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