WhichRecall
Class IIReported 2025-08-20

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

Recalled by Breckenridge Pharmaceutical, Inc.

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

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Recall Number
D-0580-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-07-25
Reported
2025-08-20
Distribution
NJ, AZ, IN
Code Info
Lot 240539C, Exp 1/31/2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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