Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica
Recalled August 20, 2025 · FDA recall D-0580-2025 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. · FDA Class II
Units
1,856 bottles
Sold at
NJ, AZ, IN
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Manufacturer(s)
Breckenridge Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →