Class IIReported 2025-12-10
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Recalled by Breckenridge Pharmaceutical, Inc.
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Recall NumberD-0216-2026ClassificationClass IIStatusOngoingCategorydrugInitiated2025-11-24Reported2025-12-10DistributionNationwide within the United StatesCode InfoLot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.