FDA Drug · D-0617-2026

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Class II · Ongoing

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Affected lots / codes — check yours against thisLot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.

Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 263 Bottles
Distribution: U.S. Nationwide
Recall initiated: June 22, 2026
Classified: June 23, 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-0617-2026%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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