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.

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Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Why: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Distributed: US Nationwide.
Company: Asclemed USA Inc.
Announced: 10 June 2026
Recall began: 14 May 2026

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