Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica
Recalled September 17, 2025 · FDA recall D-0621-2025 · Breckenridge Pharmaceutical
Hazard
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. · FDA Class II
Units
3,591 bottles
Sold at
AZ, IN, NJ
Description
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10
Manufacturer(s)
Breckenridge Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →