Duloxetine D/R recall — Class II (D-0568-2025) · pharmaranks
Class IIOngoing
Duloxetine D/R recall
FDA recall D-0568-2025 · initiated Mar 7, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Details
Product
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Recalling company
Direct Rx
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide
Initiated
Mar 7, 2025
FDA report date
Aug 13, 2025
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.