FDA Drug · D-0555-2026

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.

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Recalling firm: Asclemed USA Inc., Torrance, CA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 50 bottles
Distribution: US Nationwide.
Recall initiated: May 14, 2026
Classified: June 2, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0555-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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