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FDA · Drugs ·

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30) recall

Direct Rx recalled DULOXETINE D/R, a) 30 mg (NDC 61919-482-30) on July 1, 2026 because of cGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. It was sold nationwide.

Why it was recalled

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

What's recalled

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.

Quantity: 263 Bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Direct Rx, Dawsonville, GA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
U.S. Nationwide
Status
Ongoing
Recall number
D-0617-2026
Source
U.S. Food and Drug Administration

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