FDA Drug · D-0567-2025

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

Class II · Ongoing

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Affected lots / codes — check yours against thisLot #: 02AU2406, Exp 01/31/2027

Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 16 bottles
Distribution: Nationwide
Recall initiated: March 7, 2025
Classified: August 4, 2025
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-0567-2025%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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