Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Marto
Recalled May 13, 2026 · FDA recall D-0522-2026 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit · FDA Class II
Units
165,761 90-count bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →