Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu
Recalled December 10, 2025 · FDA recall D-0215-2026 · Breckenridge Pharmaceutical
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit · FDA Class II
Units
3397 bottles
Sold at
Nationwide within the United States
Description
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient 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 →