Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Ph
Recalled August 13, 2025 · FDA recall D-0567-2025 · Direct Rx
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. · FDA Class II
Units
16 bottles
Sold at
Nationwide
Description
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product
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
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →