Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. M
Recalled July 16, 2025 · FDA recall D-0511-2025 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II
Units
12,242 30-count bottles
Sold at
U.S. Nationwide
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →