DULOXETINE D/R recall — Class II (D-0617-2026) · pharmaranks
Class IIOngoing
DULOXETINE D/R recall
FDA recall D-0617-2026 · initiated Jun 22, 2026
By the pharmaranks editorial team·Reviewed against the FDA (openFDA) sources·Updated Jul 1, 2026·How we research
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Details
Product
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.
Recalling company
Direct Rx
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
U.S. Nationwide
Initiated
Jun 22, 2026
FDA report date
Jul 1, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.